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

Model Number M00562401

Device Problems Entrapment of Device (1212); Use of Device Problem (1670); Failure to Cut (2587)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used for a 40mm polyp resection in the colon during a colonoscopy procedure performed on (b)(6) 2022.It was reported that during the procedure and inside the patient, when the physician attempted to cut through the tissue using a lift technique, the snare would not cut and became temporarily lodged in the polyp tissue.It took a great deal of effort for the provider to dislodge the snare from the tissue and to get the device to cut through the tissue completely.Eventually, the polyp and snare were removed without causing harm to the patient.The procedure was completed with the original device used.Additionally, it was noted that the device was going to be expired on december 19, 2021, but the device was used during a procedure on (b)(6), 2022.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The complainant indicated that the device 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.

• Brand Name: CAPTIFLEX
• Type of Device: 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: 13664885
• MDR Text Key: 286754094
• Report Number: 3005099803-2022-01005
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019411
• UDI-Public: 08714729019411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2021
• Device Model Number: M00562401
• Device Catalogue Number: 6240
• Device Lot Number: 0023111349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1