MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR II; SNARE, FLEXIBLE

Model Number	M00561291
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captivator extra large round stiff snare was prepared for use during an unknown procedure performed on (b)(6) 2021.It was reported that during preparation and outside the patient, when the device was opened there was a debris on the tip of the snare.No visible issues was noted in the handle and the device.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a captivator extra large round stiff snare was prepared for use during an unknown procedure performed on (b)(6), 2021.It was reported that during preparation and outside the patient, when the device was opened there was a debris on the tip of the snare.No visible issues was noted in the handle and the device.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: (initial reporter city) (b)(6) block h6: problem code a180104 captures the reportable event of foreign material present in device.Block h10: investigation results a captivator extra large round stiff snare was received for analysis.Visual inspection of the returned device revealed that it was in good conditions and without presence of "foreign material present in device".No other issues were noted.The reported complaint of "foreign material present in device" was not confirmed since the device was visually analyzed and it was in god conditions and did not present any foreign matter upon return.Taking into consideration the evaluation conducted at the complaint investigation site (cis) and the details of the complaint, this product investigation is assigned the most probable cause classification of "no problem detected." this code was selected as the most probable complaint cause based on the information available.The product record review confirmed that this is not a new failure type and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device during visual test.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: CAPTIVATOR II
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11967256
• Report Number: 3005099803-2021-02647
• Device Sequence Number: 3172629
• Product Code: FDI
• UDI-Device Identifier: 08714729645801
• UDI-Public: 08714729645801
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: 11/04/2023
• Device Model Number: M00561291
• Device Catalogue Number: 6129
• Device Lot Number: 0026297753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1