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

Model Number	M0066703120
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(date of event): date of event was approximated to (b)(6) 2022 as no event date was reported.Initial reporter name and address: the health care facility name is (b)(6).Health care facility address: (b)(6) canada.The physician's name is unknown.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used during a flexible ureteroscopy procedure on (b)(6) 2022.During the procedure the shrink sleeve detached.The procedure was completed with the same original 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 was used during a flexible ureteroscopy procedure on (b)(6) 2022.During the procedure the shrink sleeve detached.The procedure was completed with the same original guidewire.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3 (date of event): date of event was approximated to (b)(6) 2022 as no event date was reported.Block e: the health care facility name is (b)(6).Health care facility address: (b)(6).The physician's name is unknown.Block h6 (device codes): device code a0501 is being used to capture the shrink sleeve detached.Block h10: the returned sensor wire was analyzed.The returned product was found with its sections complete (urethane tip, sleeve and ptfe coil); however, the ptfe was peeled at the long of the sheath.The initial reported event was not confirmed.Based on the condition of the returned device, engineers determined that the problem observed are related to the handling/manipulation, excess of force applied to the device or probably caused when the user used the device.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.

• 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 morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15379439
• Report Number: 3005099803-2022-05081
• Device Sequence Number: 5661530
• Product Code: EZB
• UDI-Device Identifier: 08714729376385
• UDI-Public: 08714729376385
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 05/24/2025
• Device Model Number: M0066703120
• Device Catalogue Number: 670-312
• Device Lot Number: 0029474188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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