JAGWIRE
Report
- Report Number
- 3005099803-2010-05312
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- November 30, 2010
- Report Date
- December 1, 2010
- Manufacturer
- BOSTON SCIENTIFIC - COSTA RICA
- Product Code
- EZB
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
Narratives
ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. 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 RETURNED DEVICE REVEALED THAT THE DISTAL TIP SECTION SHOWED EVIDENCE OF BEING DAMAGED. APPROXIMATELY 2.5 CM OF THE PEBAX WAS NO LONGER ATTACHED TO THE DEVICE. BASED ON THE EVIDENCE PRESENTED BY THE DEVICE, THERE IS A HIGH LIKELIHOOD THAT THE PROBABLE CAUSE FOR THE FAILURE APPEARED TO BE RELATED TO HANDLING FACTORS SINCE THIS OCCURRED DURING THE PREPARATION BEFORE TO INTRODUCE THE GUIDEWIRE TO THE WORKING CHANNEL. IT IS POSSIBLE THAT DURING REMOVAL OF THE DEVICE FROM PACKAGING HOOP, THE DEVICE MAY BECOME HUNG UP ON THE EDGE OF THE DISPENSER TUBE AND MAY HAVE BEEN PULLED AGAINST RESISTANCE THAT COMPROMISES THE INTEGRITY OF THE TIP, THEREBY CAUSING THE POLY TIP DAMAGED. ALSO THE REMNANTS OF ADHESIVE FOUND ON THE COREWIRE ON THE DISTAL TIP SHOW A PROPER ADHESION FROM THE PEBAX TO THE COREWIRE. BASED ON THE FACT THAT THE THE EVENT REPORTED WAS DURING THE PREPARATION AND THERE IS EVIDENCE OF ADHESIVE REMNANTS ON THE COREWIRE THE MOST PROBABLE ROOT CAUSE IS "HANDLING DAMAGE". A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.
NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-05313 AND 3005099803-2010-05314 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE JAG PRECURSORS WERE USED IN AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE AFTER THE GUIDEWIRE HAD BEEN FLUSHED AND REMOVED FROM ITS PACKAGING, THE DOCTOR NOTICED THAT THERE WAS DAMAGE TO THE DISTAL TIP OF THE GUIDEWIRE. ABOUT 5 CM OF THE HYDROPHILIC TIP HAD DETACHED, HOWEVER NOTHING FELL INTO THE PATIENT. THE DOCTOR EXPERIENCED THE SAME ISSUE WITH TWO MORE JAG PRECURSORS, BEFORE A FOURTH JAG PRECURSOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION HAD BEEN DESCRIBED AS "STABLE."
NOTE: THIS REPORT PERTAINS TO ONE OF THREE COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-05313 AND 3005099803-2010-05314 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE JAG PRECURSORS WERE USED IN AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE AFTER THE GUIDEWIRE HAD BEEN FLUSHED AND REMOVED FROM ITS PACKAGING, THE DOCTOR NOTICED THAT THERE WAS DAMAGE TO THE DISTAL TIP OF THE GUIDEWIRE. ABOUT 5 CM OF THE HYDROPHILIC TIP HAD DETACHED, HOWEVER NOTHING FELL INTO THE PATIENT. THE DOCTOR EXPERIENCED THE SAME ISSUE WITH TWO MORE JAG PRECURSORS, BEFORE A FOURTH JAG PRECURSOR WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION HAD BEEN DESCRIBED AS "STABLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JAGWIRE | STYLET FOR CATHETER, GASTRO-UROLOGY | EZB | BOSTON SCIENTIFIC - COSTA RICA | M0055658010 | 13244385 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |