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

Model Number M00562402

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-02932 and 3005099803-2020-02933 for the associated device information.It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, the physician attempted to use this snare with cautery but it would not cut through the target polyp since the heat would not activate nor transmit electrical current on the snare.Reportedly, the grounding pad was connected and all cables were correct.The snare was also securely attached to the active cord and there were no issues noted with the cautery pin.The generator was unplugged and restarted and the snare was extended and retracted.It was then attempted with two more of the same snares but all three were not working normally.In addition, it was noticed that the snares were large oval snares but the packaging had a picture of a small round snare.Another captiflex snare with a different lot number was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date of (b)(6), 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code 2587 captures the reportable event of snare loop failure to cut.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.Block h11: correction: sections h7 and h9.

Event Description

Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-02930, 3005099803-2020-02932 and 3005099803-2020-02933 for the associated device information.It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure peformed on an unknown date.According to the complainant, during the procedure, the physician attempted to use this snare with cautery but it would not cut through the target polyp since the heat would not activate nor transmit electrical current on the snare.Reportedly, the grounding pad was connected and all cables were correct.The snare was also securely attached to the active cord and there were no issues noted with the cautery pin.The generator was unplugged and restarted and the snare was extended and retracted.It was then attempted with two more of the same snares but all three were not working normally.In addition, it was noticed that the snares were large oval snares but the packaging had a picture of a small round snare.Another captiflex snare with a different lot number was used to complete the procedure.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
• MDR Report Key: 10312167
• MDR Text Key: 200003984
• Report Number: 3005099803-2020-02930
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501640
• UDI-Public: 08714729501640
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Device Lot Number: 0025111007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2759-2020
• Patient Sequence Number: 1