BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PGW .018 SV SHORT 300CM ST

    MDR report key: 10211248 · Received June 30, 2020

    Report

    Report Number
    1016427-2020-04106
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    June 5, 2020
    Report Date
    July 6, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K930091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, WHEN THE PHYSICIAN PULLED BACK THE .018¿ SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) A LITTLE; THE TIP OF THE WIRE BROKE OFF INSIDE THE PATIENT. THERE WAS RESISTANCE/FRICTION DURING WITHDRAWAL BETWEEN THE WIRE AND THE COMPETITOR'S CATHETER. THEREFORE, THE PHYSICIAN PROCEEDED TO TAKE THE NON-CORDIS CATHETER AND THE WIRE OUT. HOWEVER, ONCE THE DEVICE WAS OUT OF THE PATIENT IT WAS NOTICED THAT IT HAD UNRAVELED AS WELL. THE PHYSICIAN ENDED UP LEAVING THE BROKEN-OFF PIECE INSIDE THE PATIENT AND COMPLETING THE CASE WITH ANOTHER UNKNOWN WIRE. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THE WIRE WAS USED TO CROSS A CHRONIC TOTAL OCCLUSION (CTO) OF THE PERONEAL ARTERY. THE PHYSICIAN THOUGHT THAT HE MAY HAVE GONE SUBINTIMAL AND WANTED TO PULL BACK THE WIRE A LITTLE. THERE WAS NO UNUSUAL FORCED USED AFTER THE PHYSICIAN PULLED BACK ON THE WIRE. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE WIRE DID NOT BECOME KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WASN'T USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. A ¿DRILLING¿ OR ¿JACK-HAMMER¿ TECHNIQUE WASN'T USED TO RECANNULIZE THE VESSEL. THERE WAS DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL OR LESION. THE WIRE BEHAVED ¿NORMALLY¿ WITH GOOD TORQUE RESPONSE. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED. A NON-STERILE SV SHORT GUIDEWIRE (PGW .018 SV SHORT 300CM ST) WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS UNDER THE VISION SYSTEM, THE WIRE BODY WAS OBSERVED UNRAVELED/STRETCHED AND SEPARATED AT THE DISTAL TIP. NO OTHER ANOMALIES WERE OBSERVED. THE INSERTION/WITHDRAWAL TEST COULD NOT BE PERFORMED SINCE THE GUIDEWIRE WAS OBSERVED UNRAVELED/STRETCHED AND SEPARATED, AS RECEIVED. PER MICROSCOPIC ANALYSIS, SEM RESULTS SHOWED THE SEPARATED AREA OF THE BODY OF THE SV GUIDEWIRE (PGW .018 SV SHORT 300 CM ST) UNIT PRESENTED EVIDENCE OF DIAMETER REDUCTION, TENSION MARKS, AND PLASTIC DEFORMATIONS ON THE UNIT. THE PLASTIC DEFORMATIONS RESULTING IN A DIAMETER REDUCTION AND TENSION MARKS ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL OF THE GUIDEWIRE WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE WIRE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. NO OTHER ANOMALIES WERE OBSERVED DURING SEM ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 35261334 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED EVENT BY THE CUSTOMER AS ¿GUIDEWIRE - UNRAVELED/STRETCHED - IN PATIENT¿ WAS CONFIRMED SINCE THE GUIDEWIRE WAS OBSERVED UNRAVELED/STRETCHED AT THE DISTAL TIP, AS RECEIVED. THE REPORTED EVENT BY THE CUSTOMER AS ¿DISTAL TIP-WIRES - FRACTURED-SEPARATED - IN PATIENT¿ WAS CONFIRMED SINCE THE WIRE BODY OF THE UNIT WAS OBSERVED SEPARATED AT THE DISTAL TIP. THE REPORTED EVENT BY THE CUSTOMER AS ¿GUIDEWIRE - RESISTANCE/FRICTION - IN PATIENT¿ WAS NOT CONFIRMED SINCE THE INSERTION/WITHDRAWAL TEST COULD NOT BE PERFORMED DUE TO THE UNRAVELED/STRETCHED AND SEPARATED CONDITION OF THE UNIT. HOWEVER, PER MICROSCOPIC ANALYSIS, SEM RESULTS SHOWED THAT THE SEPARATED AREA OF THE UNIT PRESENTED EVIDENCE OF DIAMETER REDUCTION, TENSION MARKS AND PLASTIC DEFORMATIONS ON THE UNIT. THESE MATERIAL CHARACTERISTICS ARE COMMONLY ASSOCIATED WITH SEPARATIONS CAUSED BY MATERIAL TENSILE OVERLOAD. THEREFORE, IT IS ASSUMED THAT THE MATERIAL OF THE GUIDEWIRE WAS INDUCED TO A TENSILE FORCE THAT EXCEEDED THE WIRE MATERIAL YIELD STRENGTH PRIOR TO THE SEPARATION. PROCEDURAL/HANDLING FACTORS (DIFFICULTY TRACKING THROUGH THE VESSEL, RESISTANCE/FRICTION WITH THE NON-CORDIS CATHETER) OR VESSEL CHARACTERISTICS (CHRONIC TOTAL OCCLUSION) MAY HAVE CONTRIBUTED TO THE DAMAGE CONDITIONS FOUND ON THE UNIT. HOWEVER, THE CAUSE OF THE STRETCHED/UNRAVELED AND SEPARATED CONDITIONS COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. PER THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿GUIDEWIRE MANIPULATION/TORQUEING SHOULD ALWAYS BE PERFORMED UNDER FLUOROSCOPIC GUIDANCE. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS RESISTANCE. FIRST, USING FLUOROSCOPY, DETERMINE THE CAUSE OF RESISTANCE AND TAKE ANY NECESSARY REMEDIAL ACTION. TORQUEING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE, AND/OR GUIDEWIRE TIP SEPARATION, OR DIRECT DAMAGE TO THE VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED (VIA FLUOROSCOPY) BY NOTING ANY BUCKLING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR. IF ANY RESISTANCE IS FELT, I.E., DUE TO VESSEL SPASM, BENT GUIDEWIRE, OR GUIDEWIRE ENTRAPMENT, WHILE MANIPULATING OR REMOVING THE GUIDEWIRE IN THE BLOOD VESSEL: STOP THE PROCEDURE. DO NOT MOVE OR TORQUE THE GUIDEWIRE. USING FLUOROSCOPY, FIRST DETERMINE THE CAUSE OF THE RESISTANCE, THEN TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED. THIS MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL.¿ NEITHER THE PRODUCT ANALYSIS NOR THE PHR REVIEW RESULTS SUGGEST THAT THIS CONDITION IS RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE WAS RECEIVED FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, WHEN THE PHYSICIAN PULLED BACK THE .018¿ SV SHORT PERIPHERAL STEERABLE GUIDEWIRE (PGW) A LITTLE; THE TIP OF THE WIRE BROKE OFF INSIDE THE PATIENT. THERE WAS RESISTANCE/FRICTION DURING WITHDRAWAL BETWEEN THE WIRE AND THE COMPETITOR'S CATHETER. THEREFORE, THE PHYSICIAN PROCEEDED TO TAKE THE NON-CORDIS CATHETER AND THE WIRE OUT. HOWEVER, ONCE THE DEVICE WAS OUT OF THE PATIENT IT WAS NOTICED THAT IT HAD UNRAVELED AS WELL. THE PHYSICIAN ENDED UP LEAVING THE BROKEN-OFF PIECE INSIDE THE PATIENT AND COMPLETING THE CASE WITH ANOTHER UNKNOWN WIRE. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN A STERILE FIELD. THE WIRE WAS USED TO CROSS A CHRONIC TOTAL OCCLUSION (CTO) OF THE PERONEAL ARTERY. THE PHYSICIAN THOUGHT THAT HE MAY HAVE GONE SUBINTIMAL AND WANTED TO PULL BACK THE WIRE A LITTLE. THERE WERE NO UNUSUAL FORCED USED AFTER THE PHYSICIAN PULLED BACK ON THE WIRE. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE WIRE DID NOT KINKED OR DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THE WIRE WASN'T USED FOR TREATMENT OF ANOTHER LESION PRIOR TO THE EVENT. A ¿DRILLING¿ OR ¿JACK-HAMMER¿ TECHNIQUE WASN'T USED TO RECANALIZE THE VESSEL. THERE WAS DIFFICULTY TRACKING THE WIRE THROUGH THE VESSEL OR LESION. THE WIRE BEHAVE ¿NORMALLY¿ WITH GOOD TORQUE RESPONSE. THE DEVICE WILL BE RETURNED FOR EVALUATION. REP STATED, SECOND EVENT WITH THIS DEVICE FOR THIS CUSTOMER IN 3 WEEKS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674983 PGW .018 SV SHORT 300CM ST WIRE, GUIDE, CATHETER DQX CORDIS CORPORATION 503558X 35261334

    Patients

    Seq Age Sex Outcome Treatment
    1 QUICKCROSS CATHETER.