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

Model Number M00562402

Device Problems Entrapment of Device (1212); Retraction Problem (1536); Failure to Cut (2587); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device is not available for return; 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 Description

It was reported to boston scientific corporation that a captiflex was used during a polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, there was a cecal polyp with a larger base to it.They tried cold snare first, snare wouldn't cut through- so went to hot polypectomy using the erbe machine.Reportedly, the snare still wouldn't cut through the polyp with the heat.They were unable to get the snare off the polyp in the colon.It was reported that they kept opening and closing the snare and then suddenly couldn't close the snare, the wire inside the tubing was coiling near the handle.They kept applying heat and finally the snare came off without having to pull too hard.There were no known patient complications reported as a result of this event.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 10906182
• MDR Text Key: 219369384
• Report Number: 3005099803-2020-05653
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: 08714729501640
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0025142120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: Z-2759-2020
• Patient Sequence Number: 1