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

Model Number	M0066703121
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a sensor guidewire was used in the ureter during ureteroscopy procedure on (b)(6) 2020.According to the complainant, during the procedure, the corewire of the guidewire broke inside the ureter.The physician was able to retrieve the detached portion.The procedure was completed with a new sensor guidewire.There were no patient complications reported as a result of this event.

• Brand Name: SENSOR
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9899288
• Report Number: 3005099803-2020-01401
• Device Sequence Number: 2238361
• Product Code: EZB
• UDI-Device Identifier: 08714729257349
• UDI-Public: 08714729257349
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/30/2020

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: 11/07/2022
• Device Model Number: M0066703121
• Device Catalogue Number: 670-312
• Device Lot Number: 0024738297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/30/2020
• 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: 77 YR