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

Model Number M00562421

Device Problems Failure to Cut (2587); Human-Device Interface Problem (2949)

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

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).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 from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captiflex small oval flexible snare was used during a procedure performed on an unknown date.According to the complainant, during the procedure, there was the same known issue with the handle and the device was not cutting through the tissue.It was not reported whether the procedure was completed and it was not reported how it was completed.The patient's current condition is unavailable.

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: 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 from that review, a supplemental medwatch will be filed.Block h11: correction: sections h7 and h9.

Event Description

It was reported to boston scientific corporation that a captiflex small oval flexible snare was used during a procedure peformed on an unknown date.According to the complainant, during the procedure, there was the same known issue with the handle and the device was not cutting through the tissue.It was not reported whether the procedure was completed and it was not reported how it was completed.The patient's current condition is unavailable.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10313796
• MDR Text Key: 200066794
• Report Number: 3005099803-2020-02925
• 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: M00562421
• Device Catalogue Number: 6240-40
• Device Lot Number: 0025111007
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Removal/Correction Number: Z-2759-2020
• Patient Sequence Number: 1