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

Model Number	M0066703051
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	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3 (date of event): date of the event was approximated to (b)(6) 2023 as no event date was reported.Block h6 (device codes): imdrf device code a0501 captures the reportable event of shrink sleeve detached.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used in a procedure.The procedure date is unknown.During the procedure, the shrink sleeve detached.No further information has been obtained regarding the procedure outcome despite good faith efforts.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 in a procedure.The procedure date is unknown.During the procedure, the shrink sleeve detached.No further information has been obtained regarding the procedure outcome despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3 (date of event): date of the event was approximated to (b)(6) 2023 as no event date was reported.Block h6 (device codes): imdrf device code (b)(6) captures the reportable event of shrink sleeve detached.Block h10: the returned sensor wire was analyzed.During visual and microscope inspection, it was found that the ptfe peeled at the middle section, and the sleeve detached.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be due to interaction with the scope or other devices used in the same procedure.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 could have induced the problem observed.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 ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17064966
• Report Number: 3005099803-2023-02948
• Device Sequence Number: 15142778
• Product Code: EZB
• UDI-Device Identifier: 08714729302650
• UDI-Public: 08714729302650
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 02/05/2026
• Device Model Number: M0066703051
• Device Catalogue Number: 670-305
• Device Lot Number: 0030998065
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2023
• 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