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

Model Number	M0066703050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used during a procedure.The exact event date was not reported.During the procedure, the blue soft part on the proximal part of the guidewire was separated.The procedure was successfully completed with another sensor wire device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2023, based on the date the manufacturer became aware of the event, on (b)(6) 2023.Block e1: (b)(6).H6: imdrf device code a0501 captures the reportable event of sleeve detached.
Additional Manufacturer Narrative
Block b3: date of event was approximated to september 1, 2023, based on the date the manufacturer became aware of the event, on september 13, 2023.Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.Block h10: the returned sensor wire was analyzed, and upon magnification it was observed that the ptfe peeled at the middle section and the sleeve was detached, however the part was not returned.No other problems with the device were noted.The reported event was confirmed.With all the available information, boston scientific concludes that the reported event was confirmed.It is possible that the ptfe peeled because of an excess of force applied during the manipulation of the device during the procedure or the insertion.Also, the peeling of the ptfe could have been caused by the interaction of the guidewire with the scope or the usage of a metal needle or cannula.Additionally, the mentioned excess of force could also have contributed to the reported sleeve detachment.Based on the information available and analysis results, a conclusion code of adverse event related to procedure has been assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used during a procedure.The exact event date was not reported.During the procedure, the blue soft part on the proximal part of the guidewire was separated.The procedure was successfully completed with another sensor wire device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: SENSOR
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 17898521
• Report Number: 3005099803-2023-05300
• Device Sequence Number: 14294370
• Product Code: EZB
• UDI-Device Identifier: 08714729376354
• UDI-Public: 08714729376354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2023

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: 05/15/2025
• Device Model Number: M0066703050
• Device Catalogue Number: 670-305
• Device Lot Number: 0029411060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown