BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COUGAR GUIDE WIRE

    MDR report key: 3252899 · Received July 29, 2013

    Report

    Report Number
    1220452-2013-00038
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    May 8, 2015
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DQX
    PMA / PMN Number
    K032899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS CURRENTLY BEING PERFORMED ON THE RETURNED DEVICE. ONCE THE EVALUATION IS COMPLETED A FOLLOW- UP MEDWATCH REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE WIRE WAS RECEIVED BADLY DAMAGED SHOWING A BREAK IN THE DISTAL END OF CORE WIRE. THE COIL WIRE WAS STRETCHED AND UN RAVELED STARTING AT THE SECOND BOND JOINT. BOTH PROXIMAL BOND JOINTS ARE INTACT. FROM THE END OF THE SECOND BOND JOINT TO THE DISTAL END OF THE BROKEN CORE WIRE MEASURES APPROXIMATELY 26CM INDICATING THAT 4CM OF THE DISTAL END OF THE WIRE IS MISSING INCLUDING THE RIBBON WIRE AND DISTAL TIP. THE EVALUATION CONFIRMED THE RETURNED WIRE IS BROKE AT THE DISTAL END MISSING APPROXIMATELY 4CM OF THE DISTAL TIP OF THE WIRE. NO LOT INFORMATION WAS PROVIDED THEREFORE A REVIEW OF THE MANUFACTURING PROCESSING HISTORY CANNOT BE CONDUCTED. THE DISTAL PORTION OF THE WIRE IS REPORTED TO BE REMOVED FROM THE PATIENT AND DISCARDED. THE ROOT CAUSE RESULTING IN THE BREAK IS BELIEVED TO BE INTERFERENCE WITH MATING DEVICE. THE BREAK IN THE WIRE DOES NOT INDICATE MANUFACTURING DEFECT. THE REPORTED EVENT STATES THE WIRE WAS CAUGHT ON A STENT DURING THE CASE. THE CATH LAB MANAGER MENTIONED IN HIS REPORT THAT HE FELT THE WIRE WAS NOT AT FAULT BUT THE PHYSICIAN TECHNIQUE. THE IFU STATES DO NOT PUSH, PULL OR ROTATE WIRE AGAINST RESISTANCE IF RESISTANCE IS MET, DISCONTINUE MOVEMENT OF THE WIRE, DETERMINE THE REASON FOR THE RESISTANCE AND TAKE APPROPRIATE ACTION BEFORE CONTINUING. NO FURTHER ACTION TO BE TAKEN AT THIS TIME. (B)(4). THE ANALYSIS IS COMPLETE AS OF TODAY (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT DURING PROCEDURE AFTER USE OF WIRE AND DELIVERY OF STENTS...APPARENTLY THE WIRE TIP PROLAPSED AT TIP AND WHEN THE PHYSICIAN PULLED THE WIRE BACK WITH PROLAPSED TIP WHEN IT CAUGHT THE STENT. PROPER PHYSICIAN TECHNIQUE SHOULD HAVE BEEN TO STRAIGHTEN TIP BEFORE RETRIEVING WIRE THROUGH A NEWLY DEPLOYED STENT. THE CATH LAB MANAGER MENTIONED IN HIS REPORT THAT HE FELT THE WIRE WAS NOT AT FAULT BUT THE PHYSICIAN TECHNIQUE. DAMAGE WAS NOTED DURING INSPECTION, IT APPEARS THAT THE COIL TIP FORMING RIBBON HAS UNCOILED. PATIENT WENT TO SURGERY, CARDIAC THORACIC SURGEON REMOVED WIRE FRAGMENT. NO INJURY TO THE PATIENT. THE PORTION REMOVED FROM THE PATIENT IS NOT RETURNING. WIRE WAS REMOVED FROM THE HOOP PER IFU. LESION/VESSEL SITE, DIAGONAL BRANCH. LOCATION WITHIN ARTERY(S)DISTAL. MODERATE TORTUOSITY. ARTERY DIAMETER (IN MM) 2.5. LESION LENGTH (IN MM) 18. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A CASE CINE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT DURING PROCEDURE AFTER USE OF WIRE AND DELIVERY OF STENTS...APPARENTLY THE WIRE TIP PROLAPSED AT TIP AND WHEN THE PHYSICIAN PULLED THE WIRE BACK WITH PROLAPSED TIP WHEN IT CAUGHT THE STENT. PROPER PHYSICIAN TECHNIQUE SHOULD HAVE BEEN TO STRAIGHTEN TIP BEFORE RETRIEVING WIRE THROUGH A NEWLY DEPLOYED STENT. THE CATH LAB MANAGER MENTIONED IN HIS REPORT THAT HE FELT THE WIRE WAS NOT AT FAULT BUT THE PHYSICIAN TECHNIQUE. DAMAGE WAS NOTED DURING INSPECTION, IT APPEARS THAT THE COIL TIP FORMING RIBBON HAS UNCOILED. PATIENT WENT TO SURGERY, CARDIAC THORACIC SURGEON REMOVED WIRE FRAGMENT. NO INJURY TO THE PATIENT. THE PORTION REMOVED FROM THE PATIENT IS NOT RETURNING. WIRE WAS REMOVED FROM THE HOOP PER IFU. LESION/VESSEL SITE, DIAGONAL BRANCH. LOCATION WITHIN ARTERY(S) DISTAL. MODERATE TORTUOSITY. ARTERY DIAMETER (IN MM) 2.5. LESION LENGTH (IN MM) 18. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A CASE CINE IS AVAILABLE.

    Description of Event or Problem · 1

    AN UPDATE WAS RECEIVED FROM THE PATIENT ALLEGING THAT AS A RESULT OF THE PREVIOUSLY REPORTED EVENT, THE PATIENT SUFFERED CARDIAC ARREST, AND UNDERWENT OPEN HEART SURGERY TO REMOVE FRAGMENTS OF THE GUIDEWIRE. IT IS ALSO ALLEGED THAT HE SUSTAINED NUMEROUS PERMANENT SEQUELAE, WHICH FORCED HIM TO RETIRE EARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351863 COUGAR GUIDE WIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention