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

Model Number	M0066703120
Medical Device Problem Codes	Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device revealed that the shrink sleeve was detached from the guidewire exposing the corewire.Additionally, the shrink sleeve was slightly bent.The issue was noted during post procedure and no defects were reported by the customer during the unpacking and preparation.The issue noted (shrink sleeve detached) is an issue that could have been generated during manipulation of the device, or interaction with other devices might have impacted the integrity of the device during the procedure.All outer diameters and the length of the device were found within specification.It is important to mention that the urethane section was in good conditions, no failures were found on it, and the shrink sleeve was slightly bent but in perfect conditions.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire guidewire was used during a procedure on (b)(6) 2019 according to the complainant, the guidewire coating was peeled.The procedure was completed with this guidewire.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results: shrink sleeve detached.

• 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: 9591349
• Report Number: 3005099803-2020-00060
• Device Sequence Number: 11516179
• Product Code: EZB
• UDI-Device Identifier: 08714729376385
• UDI-Public: 08714729376385
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/15/2020

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: 06/06/2022
• Device Model Number: M0066703120
• Device Catalogue Number: 670-312
• Device Lot Number: 0023993417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2019
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1