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

Model Number	M00562402
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a captiflex medium oval flexible snare was to be used during an upper endoscopy procedure performed on an unknown date.It was reported that during the procedure, the handle broke while they were trying to close the snare with cautery.The snare was halfway through the polyp and was stuck on the polyp.The sheath was removed and another instrument was used to try to get the snare out from being embedded in the polyp.The patient was transported to yale main campus and during transport the snare came off.Reportedly, the procedure was unsuccessful.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

• Brand Name: CAPTIFLEX
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11979804
• Report Number: 3005099803-2021-02646
• Device Sequence Number: 3661055
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: 08714729501640
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention