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

Model Number	M0066703051
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hand side product of the guidewire was lifted and came off from the start of transurethral lithotripsy procedure.The procedure was completed with another of the same device.No patient complications were reported.Analysis of the retuned device identified sleeve detachment.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation result of sleeve detached.Block h11: investigation results: the returned sensor wire was analyzed, and a visual evaluation noted that the sleeve detached.During magnification, it was observed closely that the sleeve was detached, also its possible to see the remaining of the glue.There was no problem detected with polytetrafluoroethylene.The observed sleeve detachment could be related to handling and manipulation of the device during procedure, it is possible that an excess of force applied to the device such as operational factors during the use could lead to detachment of the sleeve from the guidewire.Based on the information available and analysis results, an investigation conclusion code of adverse event related to procedure has been assigned to this investigation.

• 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
• MDR Report Key: 20434960
• Report Number: 2124215-2024-63609
• Device Sequence Number: 8402689
• Product Code: EZB
• UDI-Device Identifier: 08714729302650
• UDI-Public: 08714729302650
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2024

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 Model Number: M0066703051
• Device Catalogue Number: 670-305
• Device Lot Number: 0033556982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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