JAGWIRE?
Report
- Report Number
- 3005099803-2014-03075
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- August 23, 2014
- Report Date
- August 24, 2014
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA (COYOL)
- Product Code
- EZB
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- PHYSICIAN
Narratives
A VISUAL EXAMINATION OF THE GUIDEWIRE REVEALED THAT THE DISTAL TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE AND THE DISTAL TIP IS FOUND KINKED. THE COMPLAINT IS CONSISTENT WITH THE RETURN THAT THE DISTAL TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. BASED ON ALL GATHERED INFORMATION, THE MOST PROBABLE ROOT CAUSE IS "HANDLING DAMAGE." SINCE THE MANUFACTURING OF THIS COMPLAINT DEVICE, A CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.
REPORTED EVENT OF GUIDEWIRE DISTAL TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. 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, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-03072, 3005099803-2014-03073, 3005099803-2014-03074, 3005099803-2014-03075 , 3005099803-2014-03076 AND 3005099803-2014-03077 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE JAGWIRE GUIDEWIRE WAS INSERTED INTO THE BILE DUCT, THE PHYSICIAN NOTICED THAT THE HYDROPHILIC TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. FIVE MORE JAGWIRE GUIDEWIRES WERE USED AND THE HYDROPHILIC TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE PHYSICIAN RETRIEVED THE DETACHED TIP USING A BALLOON AND THE OTHER FRAGMENTS WILL PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO SERIOUS INJURIES REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
NOTE: THIS REPORT PERTAINS TO ONE OF SIX DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2014-03072, 3005099803-2014-03073, 3005099803-2014-03074, 3005099803-2014-03075 , 3005099803-2014-03076 AND 3005099803-2014-03077 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE JAGWIRE GUIDEWIRE WAS INSERTED INTO THE BILE DUCT, THE PHYSICIAN NOTICED THAT THE HYDROPHILIC TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. FIVE MORE JAGWIRE GUIDEWIRES WERE USED AND THE HYDROPHILIC TIP DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. THE PHYSICIAN RETRIEVED THE DETACHED TIP USING A BALLOON AND THE OTHER FRAGMENTS WILL PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO SERIOUS INJURIES REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 570034 | JAGWIRE? | STYLET FOR CATHETER, GASTRO-UROLOGY | EZB | BOSTON SCIENTIFIC - COSTA RICA (COYOL) | M00556581 | 16293730 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |