MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ZEBRA; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066701101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific that a zebra guidewire was used in the ureter during ureterolithotomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noticed that the tip of the zebra guidewire was tough and pointed, indicating that the core wire broke.After several insertion, the ureteral mucosa was perforated, which created a false path.Reportedly, the ureteral mucosa was damaged and bleeding noted during the procedure.In the physician's assessment, he could not confirm whether the zebra caused or contributed to the perforation of the ureter, including the damaged ureteral mucosa, and bleeding.There was no intervention performed to address the perforation and bleeding.The procedure was completed with a second zebra guidewire.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 CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8823146
• Report Number: 3005099803-2019-03662
• Device Sequence Number: 11606388
• Product Code: EZB
• UDI-Device Identifier: 08714729191230
• UDI-Public: 08714729191230
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/29/2021
• Device Model Number: M0066701101
• Device Catalogue Number: 670-110
• Device Lot Number: 0022058374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR