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

Model Number M00562402

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

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

Event Date 09/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed 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 Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-05171 for the associated device information.It was reported to boston scientific corporation that two captiflex medium oval flexible snares were used during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, both captiflex snares were unable to cut the target polyp and had no energy.Reportedly, the generator used was an erbe endo cut.The snare was securely attached to the active cord and no visible problems were noted with the cautery pins.No other problems were noted with the devices.The procedure was completed with another captiflex 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: 12591505
• MDR Text Key: 275398689
• Report Number: 3005099803-2021-05170
• 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
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2024
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0027085177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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