MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGWIRE¿; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00556561
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).Visual examination of the returned guidewire revealed that the distal tip was detached.Presence of adhesive remnants were found indicating that the pebax was properly attached to the corewire.Evidence of corewire fractured was found since the length of the broken tip is 0.6cm.The complaint is consistent with the reported event that the distal tip of theguidewire was detached.It is most probable that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.It is most likely that during procedure the device could have been manipulated, since the failures found are issues that could have been generated by excessive manipulation of the device, also interaction with other devices might have impacted the integrity of the device during the procedure.Therefore, the most probable cause of this complaint is operational context since probably due to anatomical/procedural factors encountered during the procedure, performance was limited.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire¿ guidewire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the stent was deployed correctly in the common bile duct.When the physician tried to withdraw the delivery system , it became stuck.The stent did not move when the delivery system was pulled out.The physician ended up pulling the wire and the delivery system; however, the delivery system snapped, leaving a portion of the wire in the duct.They were able to retrieve a piece of the delivery system that broke off by using a forceps but the distal or floppy tip of the jagwire remained in the duct.Reported, the stricture was very tight.The procedure was completed with a different device by placing a 8x80 wallflex biliary uncovered stent to ensure proper drainage.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 fine.Investigation results revealed on may 28, 2018 that the core wire was broken.

• Brand Name: JAGWIRE¿
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7615913
• Report Number: 3005099803-2018-01863
• Device Sequence Number: 13809169
• Product Code: OCY
• UDI-Device Identifier: 08714729501374
• UDI-Public: 08714729501374
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00556561
• Device Catalogue Number: 5656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1