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	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned device revealed that the shrink sleeve totally detached and the shrink sleeve was not returned for analysis.The issue was noted during procedure.No defects were reported by the customer during the unpacking and preparation.The customer returned the sensor wire without the shrink sleeve therefore, no product analysis could be performed along the shrink sleeve to determine a possible failure.Additionally, the issue observed (shrink sleeve detached) could have been caused due to interaction with other devices used in the same procedure, the customer cited that the lithovue scope and a cystoscope were used with the sensor wire during the procedure.Handling/manipulation of the device and procedural factors involved could have induced the failure observed.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 review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) product label.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire guidewire was used in the kidney during a flexible ureteroscopy procedure on (b)(6) 2020.According to the complainant, during procedure, the sensor wire outer covering of the distal end was peeled and split exposing the corewire.The wire was removed and procedure was completed with a new sensor wire guidewire.There were no reported patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results: shrink sleeve detached.
Additional Manufacturer Narrative
Correction: block g3 country of event corrected to ireland based on review of the complaint record on 08dec2020.Block h6 (device codes: problem code 3211 captures the reportable investigation results of shrink sleeve detached.Block h10 (investigation results): visual examination of the returned device revealed that the shrink sleeve totally detached and the shrink sleeve was not returned for analysis.The issue happened during the procedure.There were no defects reported by the customer during unpacking or preparation of the device.The customer returned the sensor wire without the shrink sleeve therefore, no product analysis could be performed on the shrink sleeve to determine a possible failure.The shrink sleeve detachment, could have been caused due to interaction with other devices used in the same procedure.The customer cited that a lithovue scope and a cystoscope were used with the sensor wire during the procedure.Handling/manipulation of the device and procedural factors involved could have induced the failure observed.Review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire guidewire was used in the kidney during a flexible ureteroscopy procedure on (b)(6) 2020.According to the complainant, during the procedure, the coating on the sensor wire peeled and split.The wire was removed and procedure was completed with a new sensor wire guidewire.There were no reported patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results: shrink sleeve detached.Please refer to block h10 for full investigation details.

• 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: 10313312
• Report Number: 3005099803-2020-02798
• Device Sequence Number: 19623731
• Product Code: EZB
• UDI-Device Identifier: 08714729376385
• UDI-Public: 08714729376385
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2020

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: 12/08/2022
• Device Model Number: M0066703120
• Device Catalogue Number: 670-312
• Device Lot Number: 0024898135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1