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

Model Number	M0066703011
Medical Device Problem Codes	Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Block h11: the returned sensor wire was analyzed, and upon magnification it was observed that the sleeve was detached and was found peeled at the proximal side of the shaft of the device.Additionally, the sleeve 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.This could be related to handling and manipulation of the device during preparation, it is probable that an excess of force applied to the device such as operational factors during their use could lead to peel the ptfe and detached the sleeve from the sensor wire.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 that during unpacking, the coating on one end of the guidewire was peeled off.The procedure was completed with another of the same device and no patient complications were reported.Investigation results revealed that the sleeve was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h11 for full investigation details.
Event or Problem Description
It was reported that during unpacking, the coating on one end of the guidewire was peeled off.The procedure was completed with another of the same device and no patient complications were reported.Investigation results revealed that the sleeve was detached/separated, therefore this event has been deemed an mdr reportable event.
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Correction to block h11: the returned sensor wire was analyzed, and upon magnification it was observed that the sleeve was detached and was found peeled at the proximal side of the shaft of the device.Additionally, the sleeve was not returned.Media analysis did no identify any nonconformance in the device.With all the available information, boston scientific concludes that the reported event was confirmed.This could be related to handling and manipulation of the device during preparation, it is probable that an excess of force applied to the device such as operational factors during their use could lead to peel the ptfe and detached the sleeve from the sensor wire.Based on the information available and analysis results, a 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: 20045676
• Report Number: 2124215-2024-49281
• Device Sequence Number: 8043636
• Product Code: EZB
• UDI-Device Identifier: 08714729302612
• UDI-Public: 08714729302612
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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 Expiration Date: 06/05/2025
• Device Model Number: M0066703011
• Device Catalogue Number: 670-301
• Device Lot Number: 0029536228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 65 KG