Smart Port CT CT66LTPDRecalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI H787CT66LTPD0), received between Mar 6, 2017 and Oct 14, 2024 — classified as 1 death, 32 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (44 reports).

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 59 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Fracture; Difficult to Remove; Detachment of Device or Device Component; Fracture; Difficult to Remove; Detachment of Device or Device Component

  ON (B)(6) 2013, PLAINTIFF UNDERWENT PLACEMENT OF AN IMPLANTABLE VASCULAR ACCESS DEVICE AT (B)(6), WHERE SHE WAS IMPLANTED WITH AN ANGIODYNAMICS SMARTPORT PORT, REF # CT66LTPD, LOT # 587154. THE DEVICE MALFUNCTIONED, AND ON (B)(6) 2022, PLAINTIFF UNDERWENT SURGERY TO REMOVE THE SMARTPORT. HOWEVER, AFTER MULTIPLE ATTEMPTS, THE PORT COULD NOT BE REMOVED. ON (B)(6) 2023, PLAINTIFF UNDERWENT ANOTHER PROCEDURE FOR REMOVAL OF THE DEVICE. THE DEVICE HAD FRACTURED AND THE FRAGMENTED REMAINS COULD NOT BE FULLY REMOVED. 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 AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES, HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES, AND PRESENT AND FUTURE LOST WAGES.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 20442027 ↗
• 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), LOT NUMBER 5727277. THE DEVICE WAS IMPLANTED BY DR. (B)(6), 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 20441401 ↗
• DeathOct 1, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN END USER REPORTED AN ISSUE WITH A CT LOW PROFILE TITANIUM 6.6FR W/POLY CATH. DURING DEVICE REMOVAL, THE PORT WAS FOUND TO BE LEAKING CHEMOTHERAPY. IT WAS REPORTED THAT THE PATIENT LATER 'PASSED AWAY.' THERE WAS NO DIRECT ALLEGATION THAT THE PATIENT'S EXPIRATION WAS RELATED, IN ANY WAY, TO THE PORT MALFUNCTION. DESPITE NUMEROUS GOOD FAITH EFFORTS, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

  Patient problems: Infiltration into Tissue

  MAUDE report 20349334 ↗
• MalfunctionApr 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A PATIENT HAD A SMARTPORT DEVICE IMPLANTED (B)(6) 2015. WHEN PRESENTING FOR TREATMENT ON (B)(6) 2023, THERE WAS NOTED DIFFICULTY WHEN ATTEMPTING TO FLUSH THE PORT. THIS WAS AGAIN NOTED ON (B)(6) 2023. THE PATIENT PRESENTED FOR A SCAN ON (B)(6) 2023 WHICH SHOWED THE CATHETER HAD DETACHED FROM THE PORT. THE PORT WAS REMOVED AND REPLACED ON (B)(6) 2023. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020104 ↗
• MalfunctionFeb 28, 2024Infusion or Flow Problem; Infusion or Flow Problem

  A SENIOR DIRECTOR, OF ONCOLOGY SERVICE LINE, REPORTED AN ISSUE WITH A CT LOW PROFILE TITANIUM 6.6FR W/POLY CATH. THE PORT WAS PLACED FOR CHEMOTHERAPY TREATMENT; HOWEVER, AFTER ONLY 2 TREATMENTS, THE INFUSION NURSES WERE UNABLE TO ESTABLISH A BLOOD DRAW AND TPA ATTEMPTS WERE UNSUCCESSFUL. ULTIMATELY, THE PORT WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM AS A RESULT OF THIS REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800294 ↗
• InjuryDec 18, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  ANGIODYNAMICS' LEGAL DEPARTMENT RECEIVED A SUMMONS INVOLVING A CT LOW PROFILE TITANIUM 6.6FR W/POLY CATH. ON OR ABOUT ON (B)(6) 2022, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS SMARTPORT, FOR THE PURPOSE OF CHEMOTHERAPY TREATMENT. ON OR ABOUT ON (B)(6) 2022, THE DEVICE FRACTURED, CAUSING SEVERE INJURY TO THE PLAINTIFF. ON OR ABOUT ON (B)(6) 2022, THE PLAINTIFF UNDERWENT SURGERY WITH SURGICAL ASSOCIATES OF (B)(6) AT (B)(6) TO REMOVE THE PORT AND FRACTURED CATHETER. AS A RESULT OF HAVING THE SMARTPORT IMPLANTED, THE PLAINTIFF REPORTED EXPERIENCING SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, AND WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES, AND PRESENT AND FUTURE LOST WAGES. THE INJURIES, CONDITIONS, AND COMPLICATIONS SUFFERED INCLUDE BUT ARE NOT LIMITED TO HEMORRHAGE; CARDIAC/ PERICARDIAL TAMPONADE; CARDIAC ARRHYTHMIA AND OTHER SYMPTOMS SIMILAR TO MYOCARDIAL INFARCTION.

  Patient problems: Arrhythmia; Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18348060 ↗
• MalfunctionDec 29, 2022Difficult to Remove; Difficult to Remove

  THE FOLLOWING ISSUE WAS REPORTED BY A DISTRIBUTOR, CONCERNING A CT LOW PROFILE TITANIUM 6.6FR SMARTPORT: "THE CATHETER COULD NOT BE REMOVED FROM THE PORT SITE INCISION, THEREFORE, THE NECK INCISION HAD TO BE REOPENED. IT WAS ALSO ADVISED THAT THE CATHETER WAS NOTED TO BE ROUGH/ IRREGULAR ON ITS EXTERIOR AND THE SHEATH HAD TO BE PEELED OFF THE CATHETER TO FACILITATE REMOVAL. ON DOING SO, A CHALKY RESIDUE WAS NOTED WITHIN THE SHEATH AND ADHERENT TO THE CATHETER ITSELF. AFTER PEELING THIS OFF, THE CATHETER COULD THEN BE REMOVED. PATIENT HAD PROLONGED OPERATING TIME AND REQUIRED AN ADDITIONAL INCISION TO REMOVE THE PORT."

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068654 ↗
• MalfunctionDec 6, 2022Difficult to Remove; Difficult to Remove

  A DISTRIBUTOR REPORTED AN ISSUE WITH A CT LOWPROFILE TITANIUM 6.6FR W/POLY CATHETER. UPON COMPLETION OF CHEMOTHERAPY, THE PATIENT RETURNED FOR A PORT REMOVAL PROCEDURE. DURING REMOVAL, THE CATHETER WAS FOUND TO BE DIFFICULT TO REMOVE AND THE DECISION WAS MADE TO LEAVE THE RESIDUAL LINE IN SITU. THE SURGEON FEEL THAT A FIBRIN SHEATH WAS PRESENT, RESULTING IN DIFFICULTY REMOVING BECAUSE THE LINE WAS ADHERED TO THE INNER WALL OF THE VESSEL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15923551 ↗
• MalfunctionNov 4, 2022Difficult to Remove; Difficult to Remove

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN REMOVING A SMART PORT CT 6.6F. THE PORT HAD BEEN PLACED IN THE PATIENT FOR THE PURPOSES OF LONG TERM INFUSION OF MEDICATIONS AND/OR BLOOD PRODUCTS. THE PATIENT HAD BEEN DIAGNOSED WITH DBA (DIAMOND-BLACKFAN ANAEMIA) AND THE PORT WAS BEING USED FOR RECURRENT TRANSFUSIONS. IT WAS REPORTED THE DEVICE HAD BEEN INDWELLING FOR APPROXIMATELY 2.5 YEARS. WHEN ATTEMPTING TO REMOVE THE PORT AND CATHETER IT WAS REPORTED THE CATHETER WAS "STUCK IN HIS SUPERIOR VENA CAVA AND COULD NOT BE REMOVED". DUE TO UNSPECIFIED "UNFORESEEABLE EVENTS", THE CASE DID NOT PROCEED ON THE ON (B)(6) AS PLANNED. THE PATIENT WAS INSTEAD TRANSFERRED TO ANOTHER FACILITY IN (B)(4) (HOSPITAL 2) WHERE AFTER A 2ND PROCEDURE THE CATHETER/TUBING WHICH WAS "STUCK' WAS REMOVED ON (B)(6) 2022. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: Infiltration into Tissue

  MAUDE report 15734211 ↗
• MalfunctionOct 7, 2022Difficult to Remove; Obstruction of Flow; Difficult to Remove; Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT WAS AT END OF THERAPY WHEN THEY IDENTIFIED THE LINE WAS BLOCKED. WHEN REMOVING THE DEVICE, THE SURGEON REPORTEDLY OBSERVED A "TISSUE REACTION" ON THE PATIENT. THE "LINE" (CATHETER) WAS MENTIONED TO BE "BLOCKED" AND HENCE THE DECISION FOR THE REMOVAL OF THE PORT WAS MADE. THE DOCTOR MADE A PRIMARY INCISION FOR THE REMOVAL/EXPLANT OF THE PORT. IT WAS REPORTED THAT WHEN THE POCKET WAS OPENED, THE CATHETER WOULD NOT PULL OUT OF THE TUNNEL. THEREFORE, "MANY MORE" THAN USUAL ADDITIONAL INCISIONS WERE REQUIRED ON THE NECK TO APPROACH THE CATHETER FROM ANOTHER ANGLE IN ORDER TO SUCCESSFULLY REMOVE THE DEVICE. DETAILS OF THE REMOVAL PROCEDURE ARE AS FOLLOWS: ELECTIVE ADMISSION FOR REMOVAL OF RIGHT INTERNAL JUGULAR VEIN PORT AS END OF THERAPY. INCISION THROUGH PREVIOUS SCAR ADJACENT TO PORT. DISSECTION AND MOBILISATION OF PORT USING DIATHERMY, AND REMOVAL OF PROLENE STAY SUTURE. TRACTION TO CATHETER TO ATTEMPT TO REMOVE, BUT SIGNIFICANT RESISTANCE ENCOUNTERED, AND TETHERING OF CATHETER NOTED TO SUBCUTANEOUS TISSUES ALONG THE TRACT OF THE CATHETER. DISSECTION AROUND CATHETER ATTEMPTED, BUT CATHETER STILL FIXED WITHIN SUBCUTANEOUS TISSUES, AND AT NECK. PREVIOUS

  Patient problems: Infiltration into Tissue

  MAUDE report 15561367 ↗
• MalfunctionSep 20, 2021Fracture; Inability to Irrigate; Fracture; Inability to Irrigate

  ANGIODYNAMICS RECEIVED A VOLUNTARY MEDWATCH FORM, REFERENCE MW5103302, REPORTING A SMARTPORT ISSUE. PER THE REPORT, ON (B)(6) 2019, A PATIENT HAD A SMARTPORT IMPLANT PLACED FOR CHEMOTHERAPY USE. THE PATIENT WAS REFERRED FOR A PORT STUDY DUE TO THE PORT NOT FUNCTIONING. THE PORT WAS UNABLE TO BE FLUSHED OR AND BLOOD FLOW WAS UNABLE TO BE OBTAINED. THE PATIENT HAD SWELLING IN THE NECK WHEN ATTEMPTING TO FLUSH THE PORT. THE PORT STUDY WITH CONTRAST SHOWED THE CATHETER WAS FRACTURED. THE PORT WAS DEEMED UNUSABLE NOR SALVAGEABLE BY ENDOVASCULAR PROCEDURE PROVIDER, AND IT WAS RECOMMENDED TO BE REMOVED BY THE PROVIDER. ON (B)(6) 2021 THE PORT WAS REMOVED BY THE PROVIDER AND A NEW PORT WAS PLACED. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12495274 ↗
• MalfunctionJan 22, 2020Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED: WHEN PREPARING FOR A PORT PLACEMENT PROCEDURE, IT WAS NOTED THE STERILE KIT PACKAGING CONTAINED A HOLE/PUNCTURE, COMPROMISING THE STERILITY OF THE PACKAGED DEVICES. THE KIT WAS SET ASIDE AND A NEW OF TE SAME WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617310 ↗
• InjuryApr 23, 2019Material Fragmentation; Material Fragmentation

  AS REPORTED BY PATIENT: A SMART PORT WAS PLACED IN 2013. IT WAS REMOVED ON (B)(6) 2019 AT COMMUNITY MEDICAL CENTER IN (B)(6). PER PATIENT DESCRIPTION, " DR. (B)(6) WAS TRYING TO REMOVE THE PORT AND WAS PRESSING SO HARD IT FRACTURED INSIDE AND A PIECE IS LEFT INSIDE." THE PHYSICIAN INDICATED THAT IT WOULD BE ACCEPTABLE TO LEAVE THE PIECE IN PLACE."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8540656 ↗
• InjuryApr 16, 2019Microbial Contamination of Device; Microbial Contamination of Device

  ANGIODYNAMICS WAS NOTIFIED THROUGH A LETTER FROM A PATIENT THAT THEY EXPERIENCED A BACTERIAL INFECTION AFTER A SMARTPORT WAS IMPLANTED IN THEIR CHEST ON (B)(6) 2019 AT IMAGING HEALTHCARE SPECIALISTS IN CA. THE PATIENT WAS ADMITTED TO (B)(6) HOSPITAL ON (B)(6) 2019 AND THE PORT WAS REMOVED AFTER TWO SETS OF BLOOD CULTURES WERE DRAWN AN WERE POSITIVE FOR COLIFORM BACTERIAL. DNA SCREEN WAS POSITIVE FOR KLEBSIELLA. PATIENT HAD BEEN UNDERGOING FREQUENT INFUSION THERAPY FOR CHRONIC LYME DISEASE, CONSISTING OF OZONE, GLUTATHIONE, HEAVY METALS AND OTHER ALTERNATIVE THERAPIES. PORT HAD BEEN ACCESSED TWICE, MOST RECENTLY ON (B)(6) FOR OXONE INFUSION, AT WHICH TIME HE DEVELOPED SEVERE RIGORS, LOW-GRADE FEVER.

  Patient problems: Unspecified Infection

  MAUDE report 8518307 ↗
• InjuryFeb 6, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), DURING AN ATTEMPTED IMPLANTATION OF A SMART PORT, A VESSEL WAS PUNCTURED DUE TO A "RIGID GUIDEWIRE AND INTRODUCER." THE PORT WAS NOT IMPLANTED. IN THE POST-OPERATIVE PERIOD, A CHEST CT WAS PERFORMED TO ASSESS THE PATIENT'S CONDITION. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL (TRANSLATED) INFORMATION REGARDING THIS EVENT AS WELL AS THE PATIENT CONDITION.

  Patient problems: Perforation of Vessels

  MAUDE report 8311670 ↗
• InjuryFeb 6, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(6), DURING AN ATTEMPTED IMPLANTATION OF A SMART PORT, A VESSEL WAS PUNCTURED DUE TO A "RIGID GUIDEWIRE AND INTRODUCER." THE PORT WAS NOT IMPLANTED. IN THE POST-OPERATIVE PERIOD, A CHEST CT WAS PERFORMED TO ASSESS THE PATIENT'S CONDITION. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL (TRANSLATED) INFORMATION REGARDING THIS EVENT AS WELL AS THE PATIENT CONDITION.

  Patient problems: Perforation of Vessels

  MAUDE report 8311662 ↗
• InjuryFeb 6, 2019Material Too Rigid or Stiff; Material Too Rigid or Stiff

  AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN (B)(4), DURING AN ATTEMPTED IMPLANTATION OF A SMART PORT, A VESSEL WAS PUNCTURED DUE TO A "RIGID GUIDEWIRE AND INTRODUCER." THE PORT WAS NOT IMPLANTED. IN THE POST-OPERATIVE PERIOD, A CHEST CT WAS PERFORMED TO ASSESS THE PATIENT'S CONDITION. ANGIODYNAMICS IS ATTEMPTING TO OBTAIN ADDITIONAL (TRANSLATED) INFORMATION REGARDING THIS EVENT AS WELL AS THE PATIENT CONDITION.

  Patient problems: Perforation of Vessels

  MAUDE report 8311660 ↗
• InjuryJul 9, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY HOSPITAL REGARDING A SMART PORT: "REMOVAL WAS EXTREMELY DIFFICULT REQUIRING PLACEMENT OF A GUIDE WIRE THROUGH THE CATHETER TO SUPPORT IT DURING TRACTION. CATHETER BOTH ROUGHENED AND DISCOLORED. " NO DEVICE WILL BE RETURNED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7669305 ↗
• MalfunctionJul 9, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY HOSPITAL REGARDING REMOVING A SMART PORT: "MINIMAL RESISTANCE TO TRACTION. MINIMAL DISCOLORATION AND ROUGHENING." NO DEVICE WILL BE RETURNED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7669302 ↗
• MalfunctionJul 9, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY HOSPITAL REGARDING A SMART PORT: "MODERATE RESISTANCE TO TRACTION ON THE CATHETER WAS ENCOUNTERED. AS THE CATHETER WAS REMOVED A STRIP OF FIBRIN SHEATH AT LEAST TWO CM LONG WAS REMOVED WITH IT. THE CATHETER WAS ROUGH AND DISCOLORED. " NO DEVICE WILL BE RETURNED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7669301 ↗
• MalfunctionJul 9, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY HOSPITAL REGARDING A SMART PORT: "THERE WAS MILD TO MODERATE RESISTANCE TO TRACTION ON THE CATHETER AND ONCE EXPLANTED, THE CATHETER WAS MOLDLY ROUGHENED AND DISCOLORED." NO DEVICE WILL BE RETURNED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7669300 ↗
• InjuryJun 26, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT A PATIENT HAD A SMARTPORT IMPLANTED AND EXPLANTED IN 2015. IT WAS RECENTLY DISCOVERED THAT THE METAL PORT COLLAR HAD BEEN LEFT INSIDE THE PATIENT, IN THE PORT POCKET. THE COLLAR WAS THEN SURGICALLY REMOVED AND THE PATIENT CONDITION IS "OK." THE END USER HOSPITAL SUBMITTED VOLUNTARY MEDWATCH MW5077076 STATING THE COLLAR WAS "A PIECE OF THE PORT THAT IS NOT DETACHABLE." THIS IS NOT THE CASE, AS THE PORT, CATHETER, AND LOCKING COLLAR ARE PROVIDED LOOSE IN THE PORT PACKAGE AND THE CONNECTION IS MADE BY THE CLINICIAN DURING THE PORT PLACEMENT PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7638670 ↗
• InjuryMay 22, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY HOSPITAL REGARDING A SMART PORT: "MODERATE RESISTANCE - SURFACE ROUGH AS WITH MOST OTHERS." NO DEVICE WILL BE RETURNED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534216 ↗
• InjuryMay 22, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY HOSPITAL REGARDING A SMART PORT: "EXPLANT FROM GS [GENERAL SURGERY]. ANGIODYNAMIC RIGHT CHEST PORT VIA IJ. SERIOUS RESISTANCE TO REMOVAL ALONG WITH DISCOLORATION AND ROUGH SURFACE. NO DEVICE WILL BE RETURNED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534214 ↗
• InjuryMay 22, 2018Difficult to Remove; Difficult to Remove

  AS REPORTED BY HOSPITAL REGARDING A SMART PORT: "WE ENCOUNTERED MODERATELY SEVERE RESISTANCE TO REMOVAL AND THE CATHETER SURFACE WAS ROUGHENED AND DISCOLORED." NO DEVICE WILL BE RETURNED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534212 ↗