MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00556611
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr 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 stone removal procedure performed on (b)(6) 2018.According to the complainant, during the procedure, after the cannula was inserted into the patient, the jagwire guidewire was advanced into the bile duct through the cannula.The cannula was pulled out and an endoscopic sphincterotomy device was then advanced over the guidewire.However, it was noticed that the core wire of the guidewire was broken which failed the other devices to be inserted.The stump was cut using scissors, and the procedure was continued.The procedure was completed with a second jagwire guidewire.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Device codes: the problem code 1069 captures the reportable event of core wire broken.Visual examination of the returned device revealed that the ptfe peeled (exposing the corewire) at proximal end.There was no evidence of core wire fracture.Also, the guidewire was found bent at 26 cm from the proximal end.The complaint was not consistent with the reported event of broken core wire.All compiled information on this investigation determines that the most probable cause is no problem detected since the complaint included a returned device review (visual, physical, and performance testing) which showed no evidence of either the alleged issue or any defect which could have contributed to the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire guidewire was used in the common bile duct during stone removal procedure performed on (b)(6) 2018.According to the complainant, during the procedure, after the cannula was inserted into the patient, the jagwire guidewire was advanced into the bile duct through the cannula.The cannula was pulled out and an endoscopic sphincterotomy device was then advanced over the guidewire.However, it was noticed that the core wire of the guidewire was broken which failed the other devices to be inserted.The stump was cut using scissors, and the procedure was continued.The procedure was completed with a second jagwire guidewire.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 CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8147384
• Report Number: 3005099803-2018-61813
• Device Sequence Number: 2118447
• Product Code: OCY
• UDI-Device Identifier: 08714729172161
• UDI-Public: 08714729172161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/22/2019

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: 07/30/2021
• Device Model Number: M00556611
• Device Catalogue Number: 5661
• Device Lot Number: 0022447452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1