BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F BASIC TRAY WITH MICROINTROD

    MDR report key: 8139414 · Received December 6, 2018

    Report

    Report Number
    3006260740-2018-03486
    Event Type
    Injury
    Date Received
    December 6, 2018
    Report Date
    January 23, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741034589
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF RECT2287 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A BREAK IN THE 3CG STYLET WAS CONFIRMED AND ADDITIONAL INFORMATION REGARDING THIS TYPE OF COMPLAINT IS CONTAINED IN MDS-19-1373-SA. THE DISTAL END OF A 3CG STYLET WAS RETURNED FOR INVESTIGATION. THE STYLET SEGMENT, WHICH CONSISTED OF THE POLYIMIDE TUBING, CONDUCTIVE EPOXY, MAGNETS, AND CORE WIRE, WAS 3.7CM IN LENGTH. THE REMAINDER OF THE STYLET WAS NOT RETURNED FOR INVESTIGATION. THE POLYIMIDE TUBING WIRE WAS KINKED 1.9CM AND 2.7CM FROM THE DISTAL TIP OF THE STYLET. KINKS IN THE CORE WIRE COINCIDED WITH THE KINKS IN THE POLYIMIDE TUBING. A MICROSCOPIC EXAMINATION REVEALED THAT THE CONDUCTIVE EPOXY WAS 5.5MM IN LENGTH, WHICH WAS WITHIN SPECIFICATION. AN 8MM SPLIT WAS OBSERVED IN THE PROXIMAL END OF THE RETURNED SEGMENT OF POLYIMIDE TUBING. THE BREAK IN THE CORE WIRE COINCIDED WITH THE DISTAL END OF THE SPLIT, WHICH INDICATES THAT THE CORE WIRE MAY HAVE TORN THROUGH THE POLYIMIDE TUBING. THE BROKEN END OF THE POLYIMIDE TUBING WAS NOTED TO BE UNEVEN. RESIDUE FROM USE REMAINED WITHIN THE POLYIMIDE TUBING. THE WALL THICKNESS OF THE POLYIMIDE TUBING WAS WITHIN SPECIFICATION. IT WAS REPORTED THAT THE DIFFICULTY WAS ENCOUNTERED DURING INSERTION OF THE CATHETER AND REMOVAL OF THE STYLET. DAMAGE TO THE STYLET WAS REPORTEDLY OBSERVED AFTER IT WAS REMOVED FROM THE PICC. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE THE PICC LINE WAS SUCCESSFULLY PLACED UNDER FLUOROSCOPY. A LOT HISTORY REVIEW (LHR) OF RECT2287 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. B)(4).

    Description of Event or Problem · 1

    PER EMAIL: CUSTOMER HAS NOTIFIED ME (VAD SALES REP) THAT THEY HAVE ENCOUNTERED A ISSUE WITH A WIRE FROM A 3CG PICC. ON 11/13/18 ADDITIONAL DETAILS STATED: "HAD A PICC LINE PLACEMENT ATTEMPTED FOR CENTRAL VENOUS ACCESS. THE PICC LINE TEAM ENCOUNTERED DIFFICULTY THREADING THE CATHETER DESPITE REPOSITIONING IT. THEY ALSO HAD DIFFICULTY WHEN ATTEMPTING TO REMOVE THE STYLET BUT EVENTUALLY WAS ABLE TO DO SO. WHEN THE STYLET WAS REMOVED, THEY NOTED THAT THE END OF IT WAS FRAYED. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE THE PICC LINE WAS SUCCESSFULLY PLACED UNDER FLUOROSCOPY. FOLLOWING THE INSERTION, A SMALL AMOUNT OF CONTRAST WAS INJECTED TO CHECK FOR PLACEMENT. IT WAS DURING THIS INJECTION THAT A SMALL WIRE FRAGMENT FROM THE FIRST LINE ATTEMPT WAS VISUALIZED IN ONE OF THE COLLATERAL VEINS AND THEN REMOVED USING A SNARE." THE PICC LINE WAS REMOVED AND A NEW PICC WAS PLACED. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH STATED, "NO HARM TO PATIENT."

    Description of Event or Problem · 1

    PER EMAIL: CUSTOMER HAS NOTIFIED ME (VAD SALES REP) THAT THEY HAVE ENCOUNTERED A ISSUE WITH A WIRE FROM A 3CG PICC. 11/13/2018 ADDITIONAL DETAILS STATED: "HAD A PICC LINE PLACEMENT ATTEMPTED FOR CENTRAL VENOUS ACCESS. THE PICC LINE TEAM ENCOUNTERED DIFFICULTY THREADING THE CATHETER DESPITE REPOSITIONING IT. THEY ALSO HAD DIFFICULTY WHEN ATTEMPTING TO REMOVE THE STYLET BUT EVENTUALLY WAS ABLE TO DO SO. WHEN THE STYLET WAS REMOVED, THEY NOTED THAT THE END OF IT WAS FRAYED. THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY WHERE THE PICC LINE WAS SUCCESSFULLY PLACED UNDER FLUOROSCOPY. FOLLOWING THE INSERTION, A SMALL AMOUNT OF CONTRAST WAS INJECTED TO CHECK FOR PLACEMENT. IT WAS DURING THIS INJECTION THAT A SMALL WIRE FRAGMENT FROM THE FIRST LINE ATTEMPT WAS VISUALIZED IN ONE OF THE COLLATERAL VEINS AND THEN REMOVED USING A SNARE." THE PICC LINE WAS REMOVED AND A NEW PICC WAS PLACED. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH STATED, "NO HARM TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979099 POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F BASIC TRAY WITH MICROINTROD CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A RECT2287 00801741034589

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR