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

Model Number	M00562421
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snare was used during an unknown procedure performed on (b)(6) 2024.The snare partially deployed.The procedure was cancelled.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex snare was used during an unknown procedure performed on (b)(6) 2024.The snare partially deployed.The procedure was cancelled.There were no patient complications reported as a result of this event.Additional information received on december 8, 2024: the procedure was completed using a different lot from the defective product.
Additional Manufacturer Narrative
Block b5 has been updated based on the additional information received on december 8, 2024.Additional information was received that the procedure was completed using a different lot of products from the defective product.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.

• Brand Name: CAPTIFLEX
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20798643
• Report Number: 3005099803-2024-06045
• Device Sequence Number: 6833559
• Product Code: FDI
• UDI-Device Identifier: 08714729019435
• UDI-Public: 08714729019435
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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 Model Number: M00562421
• Device Catalogue Number: 6242
• Device Lot Number: 0033481957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 12/08/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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