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

Model Number	M00556591
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire¿ guidewire was used in the common bile duct during a lithotripsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure as they were capturing the stones in the left intrahepatic bile duct, cannulation was performed and was passed through the stones.Contrast imaging was then performed.After that, as they tried to exchange it but the guidewire could not be moved and was stuck in the stones.They tried to moved it several times but met with resistance the core wire was broken as well as the hydrophilic tip detached and remained on the distal part of the stones.They replaced it with a different guidewire and attempted to retrieve the stones using a retrieval balloon, however the retrieval balloon would not pass through the stones.The procedure was completed with a different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual examination of the revealed that the distal tip was partially detached, exposing the corewire.Presence of adhesive remnants were found indicating that the pebax was properly attached to the corewire.The length of the tip is 5.0cm and does not present broken sections.The complaint is not consistent with the returned device that the core wire was broken.Probably 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 failure found is an issue 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 complaint conclusion investigation code is operational context since probably due to anatomical/procedural factors encountered during the procedure, performance was limited.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire¿ guidewire was used in the common bile duct during a lithotripsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure as they were capturing the stones in the left intrahepatic bile duct, cannulation was performed and was passed through the stones.Contrast imaging was then performed.After that, as they tried to exchange it but the guidewire could not be moved and was stuck in the stones.They tried to moved it several times but met with resistance the core wire was broken as well as the hydrophilic tip detached and remained on the distal part of the stones.They replaced it with a different guidewire and attempted to retrieve the stones using a retrieval balloon, however the retrieval balloon would not pass through the stones.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• 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: 7307776
• Report Number: 3005099803-2018-00660
• Device Sequence Number: 11075131
• Product Code: OCY
• UDI-Device Identifier: 08714729501398
• UDI-Public: 08714729501398
• Combination Product (Y/N): N
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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 Expiration Date: 01/10/2020
• Device Model Number: M00556591
• Device Catalogue Number: 5659
• Device Lot Number: 20147235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 03/10/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1