JAGWIRE?
Report
- Report Number
- 3005099803-2014-02583
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- June 23, 2014
- Report Date
- July 9, 2014
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA (COYOL)
- Product Code
- EZB
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4) DISTAL TIP DETACHED EXPOSING THE COREWIRE TIP. 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.
A VISUAL EXAMINATION OF THE GUIDEWIRE REVEALED THAT THE DISTAL TIP WAS DETACHED EXPOSING THE TIP OF THE METAL COREWIRE. PRESENCE OF ADHESIVE REMNANTS WERE FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE COREWIRE. 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 INVESTIGATION FAILS TO DETERMINE A DEFINITE ROOT CAUSE. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN CANNULATED THE BILIARY PAPILLA WITH A SPHINCTEROTOME. THE JAGWIRE GUIDEWIRE WAS PLACED THROUGH THE TOME IN THE RIGHT BILE DUCT. AFTER THE SPHINCTER WAS CUT, THE TOME WAS REMOVED AND A BALLOON WAS ADVANCE OVER THE GUIDEWIRE. THE PHYSICIAN CLEANED THE COMMON BILE DUCT WITH THE BALLOON FROM SOLID SLUDGE (CASTS) AND PUSHED THE BALLOON OVER THE WIRE INTO THE RIGHT BILE DUCT. THE PHYSICIAN PULLED BACK THE BALLOON TO REMOVE THE SLUDGE. THE NURSE REMOVED THE JAGWIRE GUIDEWIRE AND NOTICED THAT THE HYDROPHILIC TIP WAS DETACHED INSIDE THE RIGHT BILE DUCT EXPOSING THE TIP OF THE METAL COREWIRE. THE DETACHED TIP WAS REMOVED DURING ANOTHER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014 USING A BASKET. 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.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN CANNULATED THE BILIARY PAPILLA WITH A SPHINCTEROTOME. THE JAGWIRE GUIDEWIRE WAS PLACED THROUGH THE TOME IN THE RIGHT BILE DUCT. AFTER THE SPHINCTER WAS CUT, THE TOME WAS REMOVED AND A BALLOON WAS ADVANCE OVER THE GUIDEWIRE. THE PHYSICIAN CLEANED THE COMMON BILE DUCT WITH THE BALLOON FROM SOLID SLUDGE (CASTS) AND PUSHED THE BALLOON OVER THE WIRE INTO THE RIGHT BILE DUCT. THE PHYSICIAN PULLED BACK THE BALLOON TO REMOVE THE SLUDGE. THE NURSE REMOVED THE JAGWIRE GUIDEWIRE AND NOTICED THAT THE HYDROPHILIC TIP WAS DETACHED INSIDE THE RIGHT BILE DUCT EXPOSING THE TIP OF THE METAL COREWIRE. THE DETACHED TIP WAS REMOVED DURING ANOTHER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2014 USING A BASKET. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451281 | JAGWIRE? | STYLET FOR CATHETER, GASTRO-UROLOGY | EZB | BOSTON SCIENTIFIC - COSTA RICA (COYOL) | M00556581 | 0016819805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |