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

Model Number	M0066703051
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire guidewire was used on (b)(6) 2022.During the procedure, the blue part of the device had come away and detached from the core wire by approximately 10 cm.The procedure was completed with another of the same sensor wire guidewire there were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire guidewire was used on (b)(6) 2022.During the procedure, the blue part of the device had come away and detached from the core wire by approximately 10 cm.The procedure was completed with another of the same sensor wire guidewire there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): device code a0401 captures the reportable event of corewire break.Block h10: the returned sensor wire guidewire was analyzed.Upon visual assessment, it was observed that the sleeve detached.The sleeve was not return.The core wire break was not confirmed because there was no evidence of this damage.Based on the condition of the returned device, engineers determined that excess force was applied in removing the wire which probably caused the detachment of the sleeve, it is most likely that as part of the device manipulation during the procedure an excess of force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope, causing the sleeve detached.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16064405
• Report Number: 3005099803-2022-07774
• Device Sequence Number: 19335248
• Product Code: EZB
• UDI-Device Identifier: 08714729302650
• UDI-Public: 08714729302650
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 02/14/2023

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: 02/07/2025
• Device Model Number: M0066703051
• Device Catalogue Number: 670-305
• Device Lot Number: 0028832848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• 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