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

Model Number	M00562341
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	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present on device.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2024.During preparation, the nurse grabbed a snare and noticed a small black hair inside the packaging of the snare.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present on device.Block h11: one captivator snare was received for analysis.Visual analysis of the unopen returned device found a foreign material inside of the pouch.No other device problems were noted.The reported event of "foreign material present in device" since it was observed that a foreign material inside was found inside the pouch nearby to the handle ring.The product record review confirmed that this was not a new failure type, and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Visual analysis found a foreign material inside the pouch.Based on the analysis of the returned device and the information available, the most probable cause is manufacturing deficiency.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used in the colon during a colonoscopy procedure performed on (b)(6) 2024.During preparation, the nurse grabbed a snare and noticed a small black hair inside the packaging of the snare.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• Brand Name: CAPTIVATOR
• 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; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19411570
• Report Number: 3005099803-2024-02451
• Device Sequence Number: 19636707
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K202478
• 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): 08/15/2024

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: M00562341
• Device Catalogue Number: 6234
• Device Lot Number: 0032868733
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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