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

Model Number M00562402

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

Lot #, expiration date, manufacture date: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The device has not been received for analysis; 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 medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the snare loop failed to cut a 3cm large polyp and became embedded in the tissue.The snare loop could not either open back fully or lift back off of the polyp.Reportedly, the snare was cut below the handle with a pair of scissors and the snare loop was cut using an endoloop cutter, however, it was unable to cut the snare loop.They went back with another captiflex snare and was able to cut the target polyp and remove the snare loop.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

Event Description

It was reported to boston scientific corporation that a captiflex medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the snare loop failed to cut a 3cm large polyp and became embedded in the tissue.The snare loop could not either open back fully or lift back off of the polyp.Reportedly, the snare was cut below the handle with a pair of scissors and the snare loop was cut using an endoloop cutter, however, it was unable to cut the snare loop.They went back with another captiflex snare and was able to cut the target polyp and remove the snare loop.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be fine.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Block h6: problem code 1212 captures the reportable event of snare loop embedded in patient's tissue.Block h10: the device was received cut in two parts (one was the handle and the other was the working length).Visual analysis of the returned device revealed that the device had flare detached.In addition, the catheter had several kinks and the loop was bent.It is most likely that the working length detachment was caused by the kinks found on the catheter, since, when the catheter is kinked, the friction between the wire and the catheter causes difficulty when actuating the device and eventually, the working length detaches from the handle.Likely the failures (working length kinks and flare detachment) caused resistance and difficulties during the procedure when attempting to cut the polyp.Based on the information available and the analysis performed, the investigation conclusion code for the encountered damages will be documented as "adverse event related to procedure." on the other hand, the reported failure "loop entrapment of device or device component" cannot be confirmed since this issue could not be replicated and verified under anatomical conditions.Therefore, the reported issue of "loop entrapment of device or device component" will be documented as "no problem detected" since the device complaint or problem cannot be confirmed.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the 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: 8628429
• MDR Text Key: 145658335
• Report Number: 3005099803-2019-02445
• 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
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562402
• Device Catalogue Number: 6240-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention