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

Model Number	M00562401
Medical Device Problem Codes	Entrapment of Device (1212); Use of Device Problem (1670); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported healthcare facility is: (b)(6).(b)(4).The complainant indicated that the device was discarded and will not be returned for evaluation; therefore, a problem 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 used during a colonoscopy polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare was unable to cut through the large polyp with the cauterizing snare.The snare became stuck on the polyp and they were unable to remove the snare to replace it with another device.The snare was cut off at the handle and the scope was removed over the snare.They reinserted the scope adjacent to the snare cord and a new snare was inserted through the channel.They removed the polyp by piece-meal towards where the old snare was caught up.The old snare eventually came off from the polyp and was able to be withdrawn from the patient.They inspected for possible wire breakage but none was noted.The procedure was completed with another captiflex snare and was able to cut and cauterize without concern using the erbe.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14408876
• Report Number: 3005099803-2022-02498
• Device Sequence Number: 5513610
• Product Code: FDI
• UDI-Device Identifier: 08714729019411
• UDI-Public: 08714729019411
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2022

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 Expiration Date: 08/28/2021
• Device Model Number: M00562401
• Device Catalogue Number: 6240
• Device Lot Number: 0022583111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown