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

Model Number M00562422

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a captiflex small oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure, the device did not generate energy for cautery and did not cut the target polyp.The snare loop was stuck to the tissue.The snare was securely attached to the active cord.There were no visible problems noted with the cautery pin and there were no other problems with the device.There were no signs of tissue blanching.The procedure was completed with a completely different snare.There were no 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
• 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: 12288959
• MDR Text Key: 265427108
• Report Number: 3005099803-2021-03940
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501657
• UDI-Public: 08714729501657
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/06/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2024
• Device Model Number: M00562422
• Device Catalogue Number: 6242-40
• Device Lot Number: 0027183974
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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