MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ZEBRA¿; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066701101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
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 zebra¿ guidewire was used in the kidney during a percutaneous nephrolithotomy (pcnl) performed on (b)(6) 2017.According to the complainant, during the procedure, the guidewire was kinked and the core wire was broken.The procedure was completed with a new zebra¿ guidewire.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.
Additional Manufacturer Narrative
Visual examination of the returned guidewire revealed that it was broken 133.5cm from the proximal.The other section was not returned.The complaint is consistent with the reported event of core wire broken.It is most probable that procedural or anatomical factors could have generated the failure encountered.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 excess of torsional force to the device by the user.Therefore, the most probable cause of this complaint is operational context.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 zebra guidewire was used in the kidney during a percutaneous nephrolithotomy (pcnl) performed on (b)(6) 2017.According to the complainant, during the procedure, the guidewire was kinked and the core wire was broken.The procedure was completed with a new zebra guidewire.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.

• Brand Name: ZEBRA¿
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6970898
• Report Number: 3005099803-2017-03265
• Device Sequence Number: 16267841
• Product Code: EZB
• UDI-Device Identifier: 08714729191230
• UDI-Public: 08714729191230
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2017

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: 01/28/2020
• Device Model Number: M0066701101
• Device Catalogue Number: 670-110
• Device Lot Number: 20219892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Initial Date Received by Manufacturer: 09/30/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 63