Smart Port CT CT80STPD-VIRecalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI H787CT80STPDVI1), received between Jan 12, 2017 and Nov 6, 2024 — classified as 1 death, 18 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Fracture” (22 reports).

2 other recalls cover devices cleared under the same FDA submission (K062414); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2020, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT PRODUCT, MODEL NUMBER H787CT80STPDVI1, LOT NUMBER 553669. THE DEVICE WAS IMPLANTED BY DR. JOHN A. HANCOCK, M.D., AT HOUSTON METHODIST SUGAR LAND HOSPITAL IN SUGAR LAND, TEXAS, FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2020, PLAINTIFF PRESENTED TO HOUSTON METHODIST SUGAR LAND HOSPITAL FOR A PORT EVALUATION DUE TO SWELLING AND ERYTHEMA AT THE PORT SITE. (B)(6) DIAGNOSED PLAINTIFF WITH CELLULITIS AND IMMEDIATELY REMOVED THE DEFECTIVE PORT. IT WAS DETERMINED THAT THE PORT HAD FRACTURED, CAUSING PLAINTIFF'S CHEMOTHERAPY TO POOL INTO HER CHEST. ON OR ABOUT (B)(6) 2020, PLAINTIFF UNDERWENT A SECOND SMARTPORT PLACEMENT TO CONTINUE HER CHEMOTHERAPY TREATMENT. THE DEVICE WAS IMPLANTED BY (B)(6) HOSPITAL. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE CORRECTIVE SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

  Patient problems: Cellulitis

  MAUDE report 20620583 ↗
• DeathNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2020, (B)(6) UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, MODEL NUMBER CT80STPD-VI, LOT NUMBER 5528064. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF PROVIDING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2022, (B)(6) PRESENTED TO (B)(6) IN (B)(6), WITH COMPLAINT OF WEAKNESS, CONFUSION, COUGH, DECREASED APPETITE, DECREASED URINE OUTPUT, AND FEVER. CT IMAGING ON OR ABOUT (B)(6) 2022, DEMONSTRATED (B)(6) HAD DEVELOPED PULMONARY EMBOLI. (B)(6) WAS HOSPITALIZED FOR MULTIPLE DAYS AND RECEIVED CARE AND TREATMENT FOR THE PULMONARY EMBOLI THAT WAS, ALLEGEDLY, CAUSED BY THE SMARTPORT. ON OR ABOUT (B)(6) 2022, (B)(6) WAS DISCHARGED HOME WITH HOSPICE SERVICES IN PLACE. ON (B)(6) 2022, (B)(6) HEALTH CONTINUED TO DECLINE, AND SHE ULTIMATELY PASSED AWAY.

  Patient problems: Confusion/ Disorientation; Cough; Fever; Muscle Weakness/Atrophy; Pulmonary Embolism

  MAUDE report 20610228 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2020, PLAINTIFF PRESENTED TO THE EMERGENCY DEPARTMENT AT (B)(6) HOSPITAL IN (B)(6), KENTUCKY, WITH COMPLAINTS OF REDNESS, SWELLING AND DRAINAGE FROM PORT SITE. BLOOD CULTURES WERE DRAWN, WHICH TESTED POSITIVE FOR ESCHERICHIA COLI. PLAINTIFF'S MEDICAL TEAM DETERMINED THAT THE SMARTPORT WAS THE SOURCE OF THE INFECTION AND NEEDED TO BE REMOVED. ON OR ABOUT (B)(6), 2020, PLAINTIFF'S DEFECTIVE DEVICE WAS EXPLANTED BY DR. (B)(6), M.D. AT (B)(6) HOSPITAL.

  Patient problems: Bacterial Infection; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 20461479 ↗
• MalfunctionOct 16, 2024Obstruction of Flow; Detachment of Device or Device Component; Migration; Obstruction of Flow; Detachment of Device or Device Component; Migration

  ON OR ABOUT (B)(6) 2017, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER CT80STPD-VI, LOT NUMBER 5197392. THE DEVICE WAS IMPLANTED BY DR. (B)(6) , M.D., AT (B)(6) HOSPITAL IN LOUISVILLE, KENTUCKY, FOR THE PURPOSE OF ONGOING VEIN ACCESS. ON OR ABOUT (B)(6) 2018, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN LOUISVILLE, KENTUCKY, TO UNDERGO FRAGMENT RETRIEVAL AND CATHETER REPLACEMENT. PLAINTIFF'S CATHETER HAD FRACTURED, MIGRATED TO THE RIGHT VENTRICLE, AND WAS ALSO OCCLUDED. THE FRAGMENT WAS SUCCESSFULLY REMOVED, AND PLAINTIFF'S CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461396 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2018, PLAINTIFF UNDERWENT PORT REPLACEMENT DUE TO THE DEVELOPMENT OF A PORT-RELATED THROMBOSIS. THE PROCEDURE WAS PERFORMED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN (B)(6). PLAINTIFF HAD AN ANGIODYNAMICS SMARTPORT PRODUCT, REFERENCE NUMBER CT80CTPDVI, IMPLANTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20461268 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS SMARTPORT, REFERENCE NUMBER (B)(4). THE DEVICE WAS IMPLANTED BY (B)(6) M.D., AT (B)(6) HOSPITAL, IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY FOR HER BREAST CANCER. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO AN INFECTION THAT CAUSED HOSPITALIZATION. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT TO LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

  Patient problems: Bacterial Infection

  MAUDE report 20440003 ↗
• InjuryOct 9, 2024Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  ON OR ABOUT (B)(6) 2015, S.E. UNDERWENT PLACEMENT OF AN ANGIODYNAMICS' SMARTPORT PRODUCT, CATALOGUE NO. CT80STPD-VI, LOT NUMBER 4820415. THE DEVICE WAS IMPLANTED BY DR. (B)(6), MD, AT (B)(6) MEDICAL CENTER IN (B)(6), FOR CHEMOTHERAPY TREATMENT FOR RECTAL CANCER. UPON INFORMATION AND BELIEF, IN OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED TO (B)(6) MEDICAL CENTER IN (B)(6), WITH THE MALFUNCTIONING SMARTPORT. AFTER ADDITIONAL TESTING, IT WAS DETERMINED THAT THE SMARTPORT HAD BROKEN AND DISLODGED INTO PLAINTIFF'S HEART. S.E.'S MEDICAL TEAM PROCEEDED TO REMOVE THE BROKEN AND DEFECTIVE SMARTPORT. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, S.E. HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT PAIN AND SUFFERING, HAS UNDERGONE ADDITIONAL SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT TO LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20409645 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANGIODYNAMICS RECEIVED A USER MEDWATCH REFERENCE MW5148479 AN END USER REPORTED, VIA A VOLUNTARY MEDWATCH, THAT A PATIENT, WHO HAD A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT, WOKE UP WITH ARM NUMBNESS AND TINGLING. THE PATIENT WENT TO THE ER AND HAD A CT SCAN AND LABS PERFORMED, WITH LIFE-THREATENING RESULTS; A SADDLE PULMONARY EMBOLISM. THE PATIENT WAS MED FLIGHTED AND TREATED WITH SURGERY AND BLOOD THINNING MEDICATIONS. THE PATIENT IS EXPERIENCING A DRY COUGH AND INCREASED SHORTNESS OF BREATH. NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Dizziness; Numbness; Pulmonary Embolism

  MAUDE report 18487105 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANGIODYNAMICS RECEIVED A USER MEDWATCH REFERENCE MW5148478. AN END USER REPORTED, VIA A VOLUNTARY MEDWATCH, THAT A PATIENT EXPERIENCED BLOOD CLOTS IN THEIR LUNGS AND MULTIPLE ISSUES SINCE HAVING A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT IMPLANTED. THE PATIENT WAS PRESCRIBED BLOOD THINNERS AROUND "(B)(6) 2023." DESPITE MULTIPLE REQUESTS, NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 18487087 ↗
• MalfunctionJan 10, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  A RISK MANAGER REPORTED AN ISSUE WITH A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT, VIA A USER FACILITY MEDWATCH ( (B)(4). THE PORT HAD BEEN PLACED FOR CHEMOTHERAPY; HOWEVER, ALMOST TWO MONTHS LATER, THE PORT WOULD NOT FLUSH OR GIVE BLOOD RETURN. A PORT FLOW STUDY CONDUCTED REVELATED THAT THE CATHETER WAS PRESENT ON THE LEFT SIDE, WITH THE TIP IN THE SUPERIOR VENA CAVA (SCV). INJECTION NOTED LEAKAGE OF CONTRAST ALONG THE SUBCLAVIAN VENOUS REGION CONSISTENT WITH DISRUPTION OF THE CATHETER TUBING. NO CONTRAST EXTENDED INTO THE DISTAL PORTION OF THE CATHETER, INTO THE SVC/HEART. THE PATIENT EXPERIENCED TEMPERATURES OF 101.7 FAHRENHEITS, ALONG WITH CHILLS FOUR DAYS LATER AND HAD THE PORT REMOVED THE SAME DAY. SYMPTOMS SUBSIDED AND THE PATIENT HAD NO FURTHER COMPLICATIONS.

  Patient problems: Failure of Implant; Fever

  MAUDE report 18487072 ↗
• MalfunctionJan 4, 2024Separation Problem; Separation Problem

  AN END USER REPORTED AN ISSUE WITH A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT. THE FOLLOWING WAS REPORTED: "WE PLACED A SMART PORT IN A PATIENT ON (B)(6) 2023. PATIENT WAS NOT SCHEDULED TO HAVE HIS FIRST TREATMENT TILL THE 6TH. WHEN CHEMO NURSE TRIED USING PORT SHE NOTICED THAT THERE WAS SWELLING IN TISSUE AROUND PORT WHEN INJECTING SALINE AND SHE COULD NOT GET ANY BLOOD RETURN. SHE CONTACTED US TO SEE IF WE COULD CHECK IT AND OUR DR. SAID TO GET A CXR. REPORT. "THE HEART SIZE APPEARS MILDLY ENLARGED. RIGHT LUNG APPEARS CLEAR AND WELL EXPANDED. THE ACCESS PORTION OF A RIGHT TRANSVENOUS MEDIPORT IS SEEN BUT THE TUBE IS NOT VISIBLE AT THIS TIME." IT WAS DISCOVERED ON THE CHEST X-RAY THAT THE CATHETER WAS NO LONGER ATTACHED TO PORT. THEREFORE THAT DAY WE HAD PATIENT CHECK IN TO SAME DAY PROCEDURES SO WE COULD LOOK FOR CATHETER AND RETRIEVE IT. SURGICAL COMPONENT: THE RIGHT GROIN WAS PREPPED AND DRAPED. REPORT. " USING ULTRASOUND GUIDANCE, THE RIGHT COMMON FEMORAL VEIN WAS PUNCTURED. A GUIDE WIRE WAS INSERTED. A SHEATH WAS PLACED. A 7-FRENCH SNARE WAS ADVANCED INTO THE MID IVC. THE DETACHED CHEMO PORT CATHETER COMPONENT WAS SNARED. THE CATHETER WAS REMOVED VIA THE FEMORAL SHEATH. HEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444429 ↗
• MalfunctionJan 4, 2024Separation Problem; Separation Problem

  ANGIODYNAMICS RECEIVED A USER MEDWATCH, REFERENCE MW5147701, REPORTING THAT A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT "BROKE OFF." NO FURTHER DETAILS WERE PROVIDED, INCLUDING PATIENT OUTCOME, FACILITY OR EVENT REPORTER.

  Patient problems: Insufficient Information

  MAUDE report 18444417 ↗
• MalfunctionJan 4, 2024Separation Problem; Separation Problem

  ANGIODYNAMICS RECEIVED A USER MEDWATCH, REFERENCE MW5147695, REPORTING THAT A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT "BROKE OFF." NO FURTHER DETAILS WERE PROVIDED, INCLUDING PATIENT OUTCOME, FACILITY OR EVENT REPORTER.

  Patient problems: Insufficient Information

  MAUDE report 18444413 ↗
• MalfunctionJan 4, 2024Separation Problem; Separation Problem

  ANGIODYNAMICS RECEIVED A USER MEDWATCH, REFERENCE MW5147700, REPORTING THAT A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT "BROKE OFF." NO FURTHER DETAILS WERE PROVIDED, INCLUDING PATIENT OUTCOME, FACILITY OR EVENT REPORTER.

  Patient problems: Insufficient Information

  MAUDE report 18444412 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED WITH A PORT FROM A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT KIT. SEVERAL MONTHS POST PROCEDURE, THE CATHETER WAS FOUND TO BE FRACTURED IMMEDIATELY PAST PORT STEM. THE PATIENT WAS TAKEN TO CATH LAB WHERE FRAGMENT OF CATHETER WAS RETRIEVED AND REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18122135 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED WITH A PORT FROM A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT KIT. SEVERAL MONTHS POST PROCEDURE, THE CATHETER WAS FOUND TO BE FRACTURED IMMEDIATELY PAST PORT STEM. THE PATIENT WAS TAKEN TO CATH LAB WHERE FRAGMENT OF CATHETER WAS RETRIEVED AND REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18120926 ↗
• InjuryOct 31, 2023Separation Problem; Separation Problem

  AN END USER REPORTED AN ISSUE WITH A W/8FR DETACHED POLY CATH W/VI SMARTPORT. A FEW WEEKS FOLLOWING DEVICE IMPLANTATION, THE CATHETER WAS FOUND TO BE FRACTURED INSIDE OF THE PATIENT. THE PATIENT REQUIRED SURGICAL REMOVAL OF THE FRAGMENT. NO FURTHER DETAILS HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18041474 ↗
• MalfunctionJul 10, 2023Infusion or Flow Problem; Material Split, Cut or Torn; Infusion or Flow Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE INFUSION RN ACCESSED THE PORT , SHE WAS ABLE TO FLUSH BUT THERE WAS NO BLOOD RETURN. THE LOCATION OF THE PORT AND CATHETER WERE CONFIRMED BY 2 OTHER RNS AND THAT THE PORT WAS ABLE TO BE FLUSHED. THE PATIENT THEN VERBALIZED THEY WERE HAVING PAIN IN THE AREA AND WOULD RATHER HAVE IV ACCESS. DUE TO THIS ISSUE, AT A LATER DATE, THE PORT WAS REMOVED AND REPLACED. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THE CATHETER WAS CRACKED, LENGTHWISE ALONG THE TUBING. THE PORT WAS BEING USED FOR CHEMOTHERAPY TREATMENT AND THE CATHETER WAS TUNNELED IN THE RIGHT SUBCLAVIAN VEIN. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288490 ↗
• MalfunctionJul 10, 2023Infusion or Flow Problem; Material Split, Cut or Torn; Infusion or Flow Problem; Material Split, Cut or Torn

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PORT FROM A CT W/8FR DETACHED POLY CATH W/VI SMARTPORT KITS. SEVERAL MONTHS POST PROCEDURE, THE INFUSION RN ACCESSED PATIENT'S PORT WITH NO BLOOD RETURNED. SHE WAS ALSO UNABLE TO TRANSFUSE THE PATIENT'S CHEMOTHERAPY TREATMENT. WHEN FLUSHING THE PORT THE SURROUNDING AREA BECAME EDEMATOUS. TWO ADDITIONAL NURSES VERIFIED PLACEMENT WITH THE SAME PROBLEM, AND THE MD WAS INFORMED. IT WAS DETERMINED TO REMOVE AND REPLACE THE PORT DUE TO THIS MALFUNCTION. WHEN THE PORT WAS REMOVED, IT WAS NOTICED THE CATHETER HAD A CRACK, LENGTHWISE ALONG THE TUBING, ANTERIORLY AND POSTERIORLY. IT IS UNKNOWN WHAT THE FREQUENCY OF USE WAS. THE PORT WAS SENT TO PATHOLOGY AND PER THE PATHOLOGIST REPORT NO BRAND OR SERIAL NUMBER IS GROSSLY IDENTIFIED. IT WAS REPORTED THE PATIENT WAS UNAFFECTED BY THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288489 ↗
• MalfunctionJan 24, 2023Fracture; Fracture

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A PORT FROM A TANDEM CT W/8FR DET POLY CATH W/VI SMARTPORT KIT. DURING A CHEMO INFUSION, A PATIENT EXPERIENCED REDNESS AND INFLAMMATION. THE PORT HAD BEEN PREVIOUSLY ACCESSED FOR CHEMO TREATMENTS WITH NO ISSUES. A CONTRAST STUDY WAS PERFORMED AND A LEAK IN THE CATHETER WAS CONFIRMED. THE DEVICE WAS REMOVED. IT IS UNKNOWN IF THE PORT WAS REPLACED AT THIS TIME.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 16232802 ↗
• MalfunctionDec 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN END USER REPORTED AN ISSUE WITH THE NEEDLES, CONTAINED IN A THE SAME CT W/8FR DET POLY CATH W/VI SMARTPORT KIT. DURING A PORT-A-CATH PLACEMENT PROCEDURE, TWO NEEDLES FROM THE SAME KIT BROKE AFTER HAVING BEEN USED ON THE PATIENT. THE FIRST NEEDLE WAS INSERTED INTO THE PATIENT AT WHICH TIME, THE NEEDLE SHAFT FRACTURE COMPLETELY FROM THE HUB OUTSIDE THE PATIENT'S SKIN, LEAVING THE NEEDLE SHAFT INSIDE THE PATIENT. THE NEEDLE SHAFT WAS REMOVED WITH NO REPORTED ISSUES. THE SECOND NEEDLE WAS INSERTED AT WHICH TIME, THE NEEDLE SHAFT BENT, BECOMING PARTIALLY DETACHED. THE PROVIDER WAS ABLE TO REMOVE THAT NEEDLE IN ONE PIECE. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068577 ↗
• MalfunctionJul 6, 2022Fracture; Fracture

  A PHYSICIAN REPORTED AN ISSUE WITH A CT W/8FR DET POLY CATH W/VI SMARTPORT DURING A ROUTINE END OF TREATMENT PORT REMOVAL PROCEDURE. DURING THE REMOVAL, AND WHILE MAKING THE PURSE STRING AROUND THE CATHETER TUBING TO CLOSE THE TUNNEL, THE PHYSICIAN PULLED THE SUTURE THROUGH TO TYING LENGTH IN PREPARATION OF REMOVING THE CATHETER. WHEN DOING SO, THE VICRYL SUTURE (NOT THE NEEDLE, BUT THE SUTURE ITSELF) COMPLETELY TRANSECTED THE CATHETER. THIS WAS BEFORE THE PHYSICIAN ATTEMPTED TO TIGHTEN IT, NEARLY LOSING A PORTION OF THE CATHETER IN THE PATIENT'S VESSEL. IN ORDER TO PREVENT MIGRATION OF THE CATHETER, THE PHYSICIAN PERFORMED SUCTION AND THEN GENTLY DISSECTED, ALLOWING FOR GRASPING OF THE CATHETER WITH HEMOSTATS.THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14929052 ↗
• MalfunctionJun 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A FEW MONTHS POST PLACEMENT OF A CT W/8FR DET POLY CATH W/VI SMARTPORT, ON MAY 11, 2022, A DYE STUDY AND FLUORO WERE PERFORMED. THESE STUDIES REVEALED A LEAK, COMING FROM A SPLIT/FRACTURE IN THE CATHETER. ULTIMATELY, THE DEVICE WAS REMOVED AND REPLACED AND THE PATIENT DID NOT EXPERIENCE ANY NOTED ADVERSE EFFECTS OR HARM AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14621508 ↗
• MalfunctionJun 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  9 MONTHS POST PLACEMENT OF A CT W/8FR DET POLY CATH W/VI SMARTPORT, ON (B)(6) 2022, A LEAK FROM THE PORT WAS NOTICED AT THE SKIN SURFACE AFTER AN INFUSION TREATMENT. THIS WAS THE RESULT OF A FRACTURE. ULTIMATELY, THE DEVICE WAS REMOVED AND REPLACED AND THE PATIENT DID NOT EXPERIENCE ANY NOTED ADVERSE EFFECTS OR HARM AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14621448 ↗
• MalfunctionMay 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT WAS DIAGNOSED WITH EWING SARCOMA AND HAD A SINGLE LUMEN SMARTPORT,LEFT SUBCLAVIAN, PORTA CATH PLACED FOR TREATMENT. AT END OF TREATMENT, THE DEVICE WAS REMOVED. AT A LATER TIME, THE PATIENT LATER RELAPSED AND REQUIRED ANOTHER PROT PLACEMENT. DURING PLACEMENT OF A NEW PORTA CATH, AN OLD, BLUE BOOT STRAIN RELIEF MECHANISM, APPROXIMATELY 1CM LONG, WAS DISCOVERED INSIDE OF THE PATIENT AND WAS SUBSEQUENTLY, REMOVED. THE PATIENT DID NOT EXPERIENCE ANY HARM AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14518083 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062414. One submission often covers many models, so check the product and lot details in each record.

• Z-1466-2021 · Feb 22, 2021 · Terminated
  Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of me
• Z-0056-2012 · Aug 1, 2011 · Terminated
  8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyur