JAGWIRE

Report

Report Number: 3005099803-2010-03849
Event Type: Malfunction
Date Received: September 13, 2010
Date of Event: July 17, 2010
Report Date: August 20, 2010
Manufacturer: BOSTON SCIENTIFIC - MIAMI
Product Code: EZB
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, AND / OR IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative · 1

THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, AND / OR IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Additional Manufacturer Narrative · 1

A VISUAL EXAMINATION REVEALED THAT THE PEBAX TUBING (APPROX 5 CM) WAS DETACHED AND NOT RETURNED FOR ANALYSIS. UPON FURTHER EXAMINATION AT 40X MAGNIFICATION, IT WAS NOTED THAT THE PTFE FLARE SURFACE APPEARS TO EXHIBIT CLEAR INDICATIONS OF HAVING BEEN SKIVED BY SOME TYPE OF DEVICE. THE CORE WIRE IS INTACT WITH NO EVIDENCE OF FRACTURE OR DETACHMENT. THE EXPOSED CORE WIRE EXHIBITS EVIDENCE OF ADHESIVE ALONG ITS LENGTH SUGGESTING THAT PEBAX TUBING WAS PROPERLY BONDED AT THE TIME OF MANUFACTURE. EXCEPT WHERE NOTED, NO OTHER DAMAGE OR INCONSISTENCIES WERE NOTED DURING THE ANALYSIS. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE TIP OF THE GUIDEWIRE WAS FOUND TO BE DETACHED. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR POSSIBLE NON-CONFORMANCES ASSOCIATED WITH THIS FAILURE MODE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS CAUSED BY OTHER DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE INSTRUCTIONS FOR USE UNDER PRECAUTIONS AND WARNINGS STATE: "CAUTION: DO NOT USE WITH METAL-TIP CATHETERS. WITHDRAWING THE GUIDEWIRE THROUGH A METAL TIP CATHETER MAY DAMAGE SURFACE OF GUIDEWIRE"

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A CHOLANGIOPANCREATOGRAPHY (CPRE) PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, AFTER SEVERAL ATTEMPTS TO PASS THE JAGWIRE THROUGH THE PAPILLA, WHICH WAS STENOSED BY A TUMOR, THE BILIARY DUCT WAS SUCCESSFULLY ACCESSED. THE BLACK TUNGSTEN TIP OF THE GUIDEWIRE WAS FOUND TO BE DETACHED COMPLETELY. IT WAS OBSERVED DISSEMINATED THROUGHOUT THE BILIARY DUCT IN MULTIPLE PARTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS A (B)(6) OLD MALE WEIGHING 54 KG. THE PROCEDURE AND SUBSEQUENT EVENT TOOK PLACE ON (B)(6), 2010. NO ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE FRAGMENTS AND THE PHYSICIAN DOES NOT ANTICIPATE ANY COMPLICATIONS AS A RESULT OF THE FRAGMENTS. THE PROCEDURE WAS CONFIRMED TO HAVE BEEN COMPLETED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE BATCH NUMBER OF THE COMPLAINT DEVICE WAS 11606207 AND THE DEVICE WAS NOT REPROCESSED. (B)(6).

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A CHOLANGIOPANCREATOGRAPHY (CPRE) PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, AFTER SEVERAL ATTEMPTS TO PASS THE JAGWIRE THROUGH THE PAPILLA, WHICH WAS STENOSED BY A TUMOR, THE BILIARY DUCT WAS SUCCESSFULLY ACCESSED. THE BLACK TUNGSTEN TIP OF THE GUIDEWIRE WAS FOUND TO BE DETACHED COMPLETELY. IT WAS OBSERVED DISSEMINATED THROUGHOUT THE BILIARY DUCT IN MULTIPLE PARTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A CHOLANGIOPANCREATOGRAPHY (CPRE) PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, AFTER SEVERAL ATTEMPTS TO PASS THE JAGWIRE THROUGH THE PAPILLA, WHICH WAS STENOSED BY A TUMOR, THE BILIARY DUCT WAS SUCCESSFULLY ACCESSED. THE BLACK TUNGSTEN TIP OF THE GUIDEWIRE WAS FOUND TO BE DETACHED COMPLETELY. IT WAS OBSERVED DISSEMINATED THROUGHOUT THE BILIARY DUCT IN MULTIPLE PARTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS A (B)(6) MALE WEIGHING (B)(6). THE PROCEDURE AND SUBSEQUENT EVENT TOOK PLACE ON (B)(6) 2010. NO ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE FRAGMENTS AND THE PHYSICIAN DOES NOT ANTICIPATE ANY COMPLICATIONS AS A RESULT OF THE FRAGMENTS. THE PROCEDURE WAS CONFIRMED TO HAVE BEEN COMPLETED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE BATCH NUMBER OF THE COMPLAINT DEVICE WAS 11606207 AND THE DEVICE WAS NOT REPROCESSED. (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	JAGWIRE	STYLET FOR CATHETER, GASTRO-UROLOGY	EZB	BOSTON SCIENTIFIC - MIAMI	M0055658011	11606207

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR