BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 2211797 · Received August 15, 2011

    Report

    Report Number
    3003775027-2011-00030
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A 2.5 X 10 MM CUTTING BALLOON WAS INSERTED OVER THE SECOND ASAHI PROWATER TO TRY CUTTING THE FIRST PROWATER; HOWEVER IT WAS UNSUCCESSFUL. THE SECOND GUIDE WIRE WAS WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE. THE ASAHI PROWATER GUIDE WIRE WAS THEN PULLED AGAIN IN AN ATTEMPT TO REMOVE FROM THE PATIENT ANATOMY AND THE GUIDE WIRE CONTINUED TO UNRAVEL. A SNARE WAS ADVANCED INTO THE AORTA. AN ATTEMPT TO SNARE THE GUIDE WIRE WAS MADE, BUT THE GUIDE WIRE SEPARATED IN THE AORTA. AN INTERVENTIONAL RADIOLOGIST WAS CALLED IN AND AN ECHOCARDIOGRAM REVEALED NO PERFORATION AND ALL REMAINING EQUIPMENT WAS REMOVED FROM THE PATIENT ANATOMY. THE PATIENT REMAINED IN STABLE CONDITION THROUGHOUT THE PROCEDURE AND WAS GIVEN ASPIRIN AND PLAVIX. AT THIS TIME, THE PATIENT REMAINS IN STABLE CONDITION AND THE DISTAL SEPARATED SEGMENT OF THE GUIDE WIRE, APPROXIMATELY 10-15 CM, REMAINS IN THE PATIENTS CIRCUMFLEX ARTERY, LEFT MAIN ARTERY AND IN THE AORTIC CUSP. THE PATIENT CONDITION WILL BE RE-EVALUATED ON (B)(6) 2011 AND FURTHER DECISIONS REGARDING INTERVENTION WILL BE MADE THEN. AS OF (B)(6) 2011, THE PATIENT CONTINUES IN STABLE CONDITION AND REMAINS UNDER OBSERVATION. THERE ARE NO PLANS FOR SURGERY TO REMOVE THE SEPARATED SEGMENT AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCTS: DIL CATH: 2.5 X 20 TREK. (B)(4) EXCESSIVE FORCE. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO., LTD. INVESTIGATION OF RETURNED PROWATER GUIDEWIRE REVEALED THAT CORE WIRE AND COIL WIRE WERE BENT AND STRETCHED FROM ITS MIDDLE BRAZING TOWARD ITS DISTAL END, BOTH WERE SEPARATED AT APPROXIMATELY 18 MM FROM MIDDLE BRAZING. THE LENGTH OF THE SEPARATED DISTAL SECTION REPORTEDLY REMAINING IN THE ANATOMY WAS ESTIMATED TO BE APPROXIMATELY 7 MM WITH CORE WIRE, APPROXIMATELY 20 MM WITH COIL (COILED LENGTH). CLOCKWISE TWISTS WERE OBSERVED CONTINUOUSLY WITH THE EXPOSED SEGMENT OF THE CORE WIRE. THE TWISTS WERE OBSERVED ESPECIALLY CONCENTRATED IN ITS DISTAL END APPROXIMATELY 1 MM, AND IT WAS HIGHLY PRESUMED THAT THE CORE WIRE WAS BROKEN APART DUE TO EXCESSIVE ROTATIONAL FORCE. THE BREAKAGE END OF THE COIL WIRE WAS FOUND REDUCED IN ITS DIAMETER, SUPPOSEDLY DUE TO THE PULLING-APART FORCE APPLIED. FROM THE INVESTIGATION RESULT OF THE RETURNED DEVICE AND PROVIDED INFORMATION ON THE PROCEDURE, IT IS CONCLUDED THAT TORQUE MANIPULATION IN THE CLOCKWISE DIRECTION WAS CONTINUOUSLY APPLIED TO THE PROWATER GUIDE WIRE AFTER ITS DISTAL END WAS STUCK IN A SIDE BRANCH, AND THAT THE CORE WAS BROKEN APART DUE TO THE FORCE EXCEEDING THE PRODUCTS DESIGN LIMIT WHEN THE GUIDE WIRE WAS WITHDRAWN WITH FORCE. THE COIL WIRE IS CONCLUDED AS HAVING BEEN PULLED APART BY FORCE WHEN SNARING WAS CONDUCTED. THE WARNING SECTION OF THE INSTRUCTIONS FOR USE DESCRIBES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. WHEN TORQUING THIS GUIDE WIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDE WIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREES) IN THE SAME DIRECTION. SEPARATION OR BREAKAGE OF THE GUIDE WIRE, IS ONE POSSIBLE COMPLICATION AND/OR ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE DISTAL CIRCUMFLEX ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION, THE ASAHI PROWATER GUIDE WIRE WAS ADVANCED TO THE LESION. A 2.5 X 20 MM TREK BALLOON DILATATION CATHETER WAS THEN ADVANCED AND INFLATED. DURING THE BALLOON ADVANCEMENT, THE ASAHI PROWATER GUIDE WIRE CAME OUT OF POSITION. THE DILATATION CATHETER WAS REMOVED FROM THE ANATOMY, AND AN ATTEMPT WAS MADE TO REPOSITION THE GUIDE WIRE; HOWEVER, THE GUIDE WIRE BECAME STUCK IN A SIDE BRANCH. THE DILATATION CATHETER WAS RE-INSERTED INTO THE PATIENT ANATOMY FOR ADDED STABILITY. AN ATTEMPT WAS MADE TO WITHDRAW THE WIRE AND DILATATION CATHETER AS ONE UNIT AND FORCE WAS APPLIED. THE PHYSICIAN REPORTED HEARING A POP AND THE GUIDE WIRE WAS OBSERVED TO BECOME UNRAVELED HALFWAY UP THE RADIOPAQUE TIP WHEN BEING WITHDRAWN. THE DILATATION CATHETER WAS REMOVED FROM THE ANATOMY WITHOUT RESISTANCE. AT THIS POINT, A SECOND ASAHI PROWATER GUIDE WIRE AND A SECOND 2.0 X 20 TREK DILATATION CATHETER WERE ADVANCED INTO THE PATIENT ANATOMY. THE BALLOON OF THE SECOND TREK DILATATION CATHETER WAS INFLATED IN AN ATTEMPT TO TRAP THE ASAHI PROWATER GUIDE WIRE AGAINST THE VESSEL WALL AND BREAK THE GUIDE WIRE. AN ATTEMPT WAS MADE TO WITHDRAW THE SECOND DILATATION CATHETER AND SECOND GUIDE WIRE WITH THE BALLOON INFLATED; HOWEVER, THE ASAHI PROWATER REMAINED INTACT. THE SECOND BALLOON WAS DEFLATED AND REMOVED FROM THE ANATOMY WITHOUT RESISTANCE. A 1.5 X 6 MM MINI TREK DILATATION CATHETER WAS THEN INSERTED OVER THE FIRST ASAHI PROWATER TO ATTEMPT REMOVAL AND THE WIRE REMAINED STUCK. THE 1.5 X 6 MM MINI TREK WAS WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 100304A561

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R