PermcathRecalls & reported problems across all models

We found 7 models of Permcath by Mozarc Medical US LLC in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2017 and Sep 27, 2024 — classified as 2 deaths, 9 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Permcath problems

Permcath models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Permcath 8817748001

  CATHETER, SUBCLAVIAN
  2 deaths34 reports
• Permcath 8817749001

  CATHETER, SUBCLAVIAN
  7 reports
• Permcath 8834369001

  CATHETER, SUBCLAVIAN
  4 reports
• Permcath 8815132001

  Cannula, A-V Shunt
  2 reports
• Permcath 8888169001

  Accessories, a-v shunt
  2 reports
• Permcath 8831692001

  CATHETER, SUBCLAVIAN
  1 report
• Permcath 8817680001

  CATHETER, SUBCLAVIAN
  1 report

Recent Permcath adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Material Puncture/Hole; Pumping Problem; Material Puncture/Hole; Pumping Problem

  ACCORDING TO THE REPORTER, AFTER SURGERY, BLOOD LEAKAGE WAS FOUND IN THE SILICONE TUBE OF THE INTRAVENOUS CONNECTOR. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AT THE VENOUS CONNECTOR SILICONE TUBE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323450 ↗
• MalfunctionSep 19, 2024Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, DURING INTUBATION OF THE CATHETER, THE CATHETER SHAFT WAS KINKED AND THE CATHETER COULD NOT BE PLACED. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE INSERTION SITE WAS TREATED WITH BETADINE PRIOR TO PRODUCT PLACEMENT. FLUSHING WAS NOT DONE PRIOR TO USE. THE PRODUCT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND LOT ON THE SAME DAY, AND THIS RESOLVED THE ISSUE AND THE TREATMENT WAS COMPLETED. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED DUE TO THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20257166 ↗
• MalfunctionAug 26, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING CATHETER INSERTION, WHEN THE LONG-TERM DOUBLE-LUMEN CATHETER WAS LED OUT OF THE TUNNEL, THE TUNNEL DEVICE CONNECTOR BROKE (THE TUNNEL DEVICE STEEL BAR WAS DISCONNECTED FROM THE PLASTIC CONNECTOR), RESULTING IN THE CATHETER BEING UNABLE TO PASS THROUGH THE TUNNEL AND THE OPERATION BEING UNABLE TO CONTINUE. THE IMPACTS ON THE PATIENT WERE EXTENDED OPERATION TIMES, INCREASED BLEEDING, AND INCREASED MEDICAL EXPENSES. A TEMPORARY CATHETER WAS USED INSTEAD, OR A SECOND SET OF PRODUCTS WAS USED. AT THAT TIME, IT WAS DECIDED TO USE A TEMPORARY HEMODIALYSIS CATHETER TO QUICKLY ESTABLISH DIALYSIS ACCESS. THE PATIENT'S CONDITION IMPROVED AFTER RECEIVING DIALYSIS TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071260 ↗
• MalfunctionJul 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD THREE HOLES IN THE BODY. THERE WAS A LEAK ON THE CATHETER SHAFT. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT USED. THERE WAS NO PROBLEM WITH LUER ADAPTER. NO DISINFECTANT WAS USED TO DISINFECT THE CATHETER. NO WOUND DRESSING HAD BEEN USED. SEPSIDERM TO CLEAN THE CATHETER WAS NOT USED. NO PROTOCOL WAS CHANGED FOR CLEANING AGENTS USED RECENTLY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE. FLUSHING WAS DONE PRIOR TO USE, AND NO ABNORMALITIES WERE FOUND. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. AS A REMEDIAL ACTION, THE SURGEON REPLACED IT ON THE SPOT WITH A NEW CATHETER FOR THE PATIENT. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO BLOOD LOSS, AND A BLOOD TRANSFUSION WAS NOT REQUIRED DUE TO THE EV ENT. NO INTERVENTION OR TREATMENT WAS REQUIRED DUE TO THE REPORTED PRODUCT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813152 ↗
• MalfunctionFeb 7, 2024Break; Break

  ACCORDING TO THE REPORTER, AFTER SURGERY, THERE WERE CRACKS AND BLOOD LEAK AT THE CATHETER MAIN BODY SPECIFICALLY AT THE SLEEVE. THE LEAKAGE WAS LOCATED OUTSIDE THE BODY. THERE WAS NO LEAK AT THE JUNCTION OF THE BIFURCATE AND CATHETER. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. BESIDES THE REPORTED ISSUE THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. SEPSIDERM WAS NOT USED TO CLEAN THE CATHETER. THERE WAS NO OINTMENT(S) UTILIZED AT THE EXIT SITE. WOUND DRESSING WAS NOT UTILIZED. THE TREATMENT (LOTIONS/OINTMENTS, MEDICATIONS) WAS NOT USED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE PATIENT WAS TREATED UNDER LOCAL ANESTHESIA. THE CATHETER WAS NOT REPAIRED. AS A REMEDIAL ACTION THE REPORTED CATHETER WAS EXPLANTED AND REPLACED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO MEDICAL INTERVENTION/TREATMENT DONE TO THE PATIENT AS A RESULT OF THE EVENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS RELATED TO TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18664513 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT PRESENTED DUE TO INTERMITTENT CHEST PAIN WITH NAUSEA AFTER GETTING ¿PERMCATH¿ REPLACED AFTER MISSING DIALYSIS. IT WAS ALSO STATED THAT THE PATIENT SUFFERED FROM TYPE 1 SPONTANEOUS MYOCARDIAL INFARCTION WITH UNKNOWN LOCATION LATER AFTER THE PATIENT RECEIVED ¿PERMCATH¿. THE PATIENT WAS HOSPITALIZED FROM ¿(B)(6) 2023¿. IT WAS KNOWN THAT THERE WAS ELEVATED TROPONINS FROM ¿(B)(6) 2023¿= 322NG/L (NANOGRAMS PER LITER) TO 579NG/L ON ¿(B)(6) 2023¿. IT WAS STATED THAT IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY WAS HELD FOR PERMCATH PROCEDURE. IT WAS ALSO UNKNOWN IF HOLDING ANTIPLATELET LED TO CHEST PAIN. THE PATIENT WAS A FORMER SMOKER. DUE TO UNDERLYING METASTATIC LUNG CANCER WITH PROGRESSIVE FUNCTIONAL, GENERAL HEALTH DECLINE AND THERE WAS POOR TOLERANCE OF TREATMENTS. A HEART CATH WAS NOT PURSUED, INSTEAD MEDICAL TREATMENT WITH ASPIRIN AND PALLIATIVE CARE WAS CONSULTED AND TAKEN IN RESPONSE TO THIS AE (ADVERSE EVENT). THE AE WAS ALSO NOT TREATED WITH A PERCUTANEOUS TRANSLUMINAL CORONARY INTERVENTION. THERE WAS NO SURGICAL PROCEDURE DONE. AE (ADVERSE EVENT) WAS SUBMITTED NOW DUE TO THERAPY RELEVANCE. IT WAS MENTIONED THAT BASED ON THE SPONSORS ASSESS

  Patient problems: Chest Pain; Myocardial Infarction; Nausea

  MAUDE report 18589751 ↗
• MalfunctionNov 10, 2023Product Quality Problem; Unraveled Material; Product Quality Problem; Unraveled Material

  ACCORDING TO THE REPORTER, DURING CATHETERIZATION SURGERY, THE GUIDE WIRE WITHIN THE KIT HAD BEEN USED, WAS STUCK IN THE NEEDLE TIP UPON REMOVAL OR WITHDRAWAL, AND IT WAS WORN. HOWEVER, IT WAS STATED THAT THE GUIDE WIRE AND THE NEEDLE DID NOT NEED TO BE REMOVED FROM THE PATIENT SIMULTANEOUSLY DUE TO THE ALLEGED DEFECT, AS THE GUIDEWIRE WAS REMOVED ALONE. THE GUIDE WIRE WAS REMOVED BY HAND, AND NO TOOLS WERE USED. IT WAS ALSO STATED THAT THE GUIDE WIRE WAS STILL INTACT AND SLIGHTLY BENT WHEN IT WAS REMOVED, BUT IT WAS NOT BENT AND WAS NOT WORN WHEN UNPACKING AND PRIOR TO INSERTION INTO THE PUNCTURE NEEDLE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS DONE PRIOR TO USE WITH A NORMAL RESULT. TEGO WAS NOT UTILIZED, AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. IOD OPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. THE INSERTION SITE WAS TREATED WITH IODOPHOR PRIOR TO PRODUCT PLACEMENT. THE CATHETER WAS NOT RE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18115020 ↗
• MalfunctionOct 20, 2023Break; Break

  ACCORDING TO THE REPORTER, AT 15:30, THE DOCTOR WAS REPLACING THE HEMODIALYSIS TUBE AND ACCESSORIES OF THE PATIENT. NEAR THE END OF THE OPERATION, WHEN PREPARING TO CONNECT THE LUER ADAPTER (STERILE INFUSION CONNECTOR) TO THE PATIENT, IT WAS DISCOVERED THAT ONE OF THE LUER ADAPTERS WAS DAMAGED. THE VENOUS/BLUE LUER ADAPTER HAD A CRACK AND A LEAK WAS OBSERVED IN THE CRACKED AREA. THE PATIENT'S PULSE RATE PER MINUTE WAS 80 TIMES/MINUTE, BREATH RATE PER MINUTE WAS 19 TIMES/MINUTE AND BP (BLOOD PRESSURE) WAS 140/85MMHG. THE PATIENT DID NOT COMPLAIN OF DISCOMFORT. TEGO WAS UTILIZED AND THE CATHETER WAS REPAIRED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. IODOPHOR WAS THE CLEANING AGENT UTILIZED TO CLEAN THE ADAPTERS. THE DEVICE WAS NOT REPLACED WITH A NEW PRODUCT AND THE CATHETER WAS NOT EXPLANTED. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. A SALINE WAS USED TO FLUSH THE DEVICE PRIOR TO USE AND HAD NO ISSUES. THEY IMMEDIATELY REPLACED THE LUER ADAPTER WITH A SPARE LUER ADAPTER OR DISPOSABLE STERILE INFUSION CONNECTOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980922 ↗
• MalfunctionOct 16, 2023Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  ACCORDING TO THE REPORTER, WHILE PULLING OUT/REMOVING THE GUIDE WIRE, IT WAS STUCK AND DEFORMED (UNTANGLED). THE GUIDE WIRE WAS NEEDED TO BE TAKEN OUT TOGETHER WITH THE NEEDLE/CATHETER IN ONE ACTION. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED WITH IODOPHOR PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. FLUSHING WAS DONE PRIOR TO INSERTION AND HAD A NORMAL OUTCOME. THE GUIDE WIRE USED WAS ONE INCLUDED IN THE KIT. EXCESSIVE FORCE WAS APPLIED ON INSERTION AND WITHDRAWAL OF THE GUIDE WIRE AND THERE WAS NO RESISTANCE WHEN INSERTING THE GUIDE WIRE. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSION AND THERE WAS NO OCCLUSION NOTED. THE GUIDE WIRE WAS INTACT, DID NOT BREAK INTO PIECES AND IT WAS REMOVED MANUALLY. THE PRODUCT WAS REPLACED WITH A NEW DEVICE FROM A DIFFERENT VENDOR TO RESOLVE THE ISSUE AND PROCEDURE WAS COMPLETED. THERE WAS BLOOD LOSS OF ABOUT 1ML AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/MEDICAL TREAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17946018 ↗
• MalfunctionSep 13, 2023Break; Break

  ACCORDING TO THE REPORTER, APPROXIMATELY TWO MONTHS AFTER THE CATHETERIZATION PROCEDURE WAS PERFORMED, BLOOD LEAKAGE WAS FOUND IN THE MAIN BODY. ALSO, A LEAK WAS FOUND AT THE CATHETER SHAFT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. THE PATIENT WAS TREATED WITH LOCAL ANESTHESIA. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, AND THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THE LUMENS WERE NOT FLUSHED PRIOR TO USE. THERE WERE NO DEFECTS OR DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. IODOPHOR WAS USED AS A CLEANING AGENT TO CLEAN THE CATHETER, AND GAUZE WAS USED FOR WOUND DRESSING. THERE WERE NO CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES INCLUDED IN THE WOUND DRESSING. THE CLEANING AGENT WAS DRIED THOROUGHLY PRIOR TO DRESSING THE AREA AND APPLYING THE OINTMENT TO IT. THE PATIENT WAS NOT RESPONSIBLE FOR THE CATHETER MAINTENANCE. THE PATIENT WAS NOT USING ANY TYPE OF ANTIBIOTIC ON THE CATHETER. THE CLEANING AGENT WAS NOT SWITCHED OVER THE LIFE OF THE CATHETER AND WAS NOT MIXED. SEPSIDERM WAS NOT USED TO CLEAN THE CATHETER. THERE WERE NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17741191 ↗
• MalfunctionJun 23, 2023Break; Break

  ACCORDING TO THE REPORTER, DUE TO UREMIA, THE PATIENT HAD A SEMI-PERMANENT CATHETER PLACED IN THE RIGHT NECK, AND DURING THE HEMODIA LYSIS PROCESS, THE DOCTOR FOUND A SMALL AMOUNT OF BLOOD OOZING FROM THE CATHETER. THEY CHECKED THE CATHETER IMMEDIATELY AND FOUND THAT THE VENOUS LUER ADAPTER OF THE CATHETER WAS SPLIT (A MATERIAL FRACTURE OR BREAK). NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE PRODUCT WAS FLUSHED PRIOR TO USE, AND THE RESULT WAS NORMAL: THE FITTINGS WERE CLEAN AND IT WAS FLUSHED PROPERLY. THE ADAPTERS WERE HAND-TIGHTENED. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. SALINE WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE ADAPTERS. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. TEGO WAS NOT UTILIZED. THEY IMMEDIATELY GAVE BACK BLOOD TO GET OFF THE MACHINE, SEALED THE TUBE WITH HEPARIN, AND THE PROCESS WENT SMOOTHLY. THE DOCTOR WHO PLACED THE CATHETER WAS CONTACTED AND CONSIDERED REPLACING THE CATHETER TIP AT AN OPTIONAL TIME, AND THE PATIENT WAS INFORMED OF THE RELEVANT PRECAUTIONS AND THAT IF THERE WERE SPECIAL CIRCUMS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195549 ↗
• MalfunctionMay 26, 2023Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, FOUR DAYS AFTER IMPLANTATION, DURING DIALYSIS TREATMENT, THE PRODUCT HAD ARTERIAL (RED) LUMEN TIP OR VENOUS (BLUE) END BLOCKAGE, AFFECTING THE PATIENT'S DIALYSIS. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS NOT DONE PRIOR TO USE. THERE WAS NO PROBLEM WITH THE CATHETER'S DIMENSIONS. THE DIMENSION OF THE CATHETER MATCHED WHAT WAS INDICATED ON THE LABEL. NO CLEANING AGENT WAS USED ON THE DEVICE. NO TEGO WAS UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE CUSTOMER TRIED TO REVERSE THE LINES. THEY ADJUSTED THE CATHETER'S POSITION AND SEALED THE TUBE WITH UROKINASE. CONTINUOUS UROKINASE SEALING WAS THE INTERVENTION OR TREATMENT USED. AFTER CONTINUOUS UROKINASE LOCK FOR SEVERAL DAYS, CATHETER PATENCY WAS OBSERVED. THEY STILL REMOVED AND REPLACED THE TEMPORARILY LONG-TERM TUBE WITH A NEW ONE WITH THE SAME PRODUCT ID (IDENTIFIER) ON (B)(6) 2023. THE TREATMENT WAS PERFORMED AND COMPLETED AFTERWARDS. THE PROCUREMENT CENTER HAD CONTACTED THE SUPPLIER TO COME TO THE HOSPITAL TO CHECK AND REPLACE THE PROBLEMATIC BATCH. THERE WAS NO BLOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010626 ↗
• InjuryMay 15, 2023Break; Migration; Break; Migration

  ACCORDING TO THE REPORTER, THE CATHETER WAS DECIDED TO BE WITHDRAWN/REMOVED BECAUSE THERE WAS ALREADY A FUNCTIONAL FISTULA, AND THE CATHETER WAS NO LONGER NEEDED. HOWEVER, DURING REMOVAL IN OPERATING ROOM (OR), THE CATHETER WAS RUPTURED. IT WAS STATED THAT THE LUMP (BROKEN CATHETER PIECE) OF APPROXIMATELY 10 CM (CENTIMETER) HAD FELL INTO THE PATIENT¿S BODY AND MIGRATED INTO THE LEFT PULMONARY ARTERY WITH HYPOXIC RESPIRATORY DISTRESS AND CHEST PAIN. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO PRESCRIBED/OVER-THE-COUNTER TREATMENT (LOTIONS/OINTMENTS). THE SITE WAS NOT USING SEPSIDERM TO CLEAN CATHETERS. THERE WAS NO RECENT CHANGE IN PROTOCOL FOR CLEANING AGENTS USED. THE BLOCK (MIGRATED PIECE) WAS ATTEMPTED TO BE REMOVED IN THE FACILITY¿S OPERATING ROOM (OR) ON THE SAME DAY OF THE EVENT, BUT THE PATIENT WAS DISCHARGED FROM INTENSIVE CARE UNIT TO NEPHROLOGY WITH NO RETURN TO BASIC STATE IN WHICH HE WAS AT THE ADVENT OF THE INCIDENT. THE PATIENT WAS TRANSFERRED TO A DIFFERENT SURGICAL CENTER ON APRIL 25, 2023 FOR 48 HOURS FOR ENDOVASCULAR ABLATION TO REMOVE THE MIGRATE

  Patient problems: Chest Pain; Foreign Body In Patient; Respiratory Insufficiency

  MAUDE report 16929885 ↗
• MalfunctionApr 21, 2023Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS FLUSHED BEFORE THE SURGERY, IT WAS FOUND THAT THE VENOUS SILICONE EXTENSION TUBE HAD LEAKED WATER NEAR THE BIFURCATE WHERE HOLES/CUT OBSERVED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. NO DAMAGE TO THE OUTER PACKAGING. NO DAMAGE TO THE INNER PACKAGING AND THE STERILE BARRIER WAS INTACT. NO EXCESSIVE FORCE APPLIED ON THE PRODUCT. NO CLEANING AGENT USED ON THE DEVICE. THE PRODUCT WAS NEVER IMPLANTED, IT WAS REPLACED WITH THE SAME PRODUCT ID (IDENTIFIER) AND SAME LOT ON THE SAME DAY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16788375 ↗
• MalfunctionApr 3, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING CATHETERIZATION, WHEN THE GUIDEWIRE WITHIN THE KIT WAS IMPLANTED, IT WAS STUCK IN THE NEEDLE AND CANNOT BE IMPLANTED OR WITHDRAWN. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. FLUSHING WAS PERFORMED AND IT WAS FULLY FLUSHED. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. TEGO WAS NOT UTILIZED AND NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. THE CLEANING AGENT USED ON THE DEVICE WAS SALINE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. AS A RESULT OF THE EVENT, HEMOSTASIS AND RE-CANNULATION WITH ANOTHER HEMODIALYSIS CATHETER WAS REQUIRED AS AN INTERVENTION. THERE WAS A BLOOD LOSS OF ABOUT 5 MILLILITER (ML), AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE TREATMENT WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16664057 ↗

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