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

Model Number M00562471

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

(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 extra small oval flexible snare was used in the transverse colon during a colonoscopy procedure on (b)(6) 2019.According to the complainant, during the procedure, the snare loop and delivery system wire was completely pulled apart.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be healthy.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a captiflex extrasmall oval flexible snare was used in the transverse colon during a colonoscopy procedure on (b)(6) 2019.According to the complainant, during the procedure, the snare loop and delivery system wire was completely pulled apart.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be healthy.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: problem code 2907 captures the reportable event of snare loop detachment.Block h10: visual evaluation of the returned device revealed that the device has the working length detached from the handle.A kink was noted on catheter and in the component wire near the handle.These failures may occur when the catheter/wire is kinked.The friction between the wire and the catheter causes difficulty actuating and eventually, the working length detaches from the handle.Upon further investigation, it can be noted that there was also evidence of flaring process.However, the investigation was unable to confirm the reported events of loop detachment of device and wire break since the loop and wire were not detached or broken upon return.According to the complainant, during the procedure, the snare loop and delivery system wire was completely pulled apart.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be healthy.The failures observed in the returned device and the failures reported by the physician may be related to some factors; handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure could have possibly affected the device performance and its integrity contributing to the failure experienced by the customer.A risk review of the captiflex - snares was completed using the polypectomy snares risk mgmt workbook, bsc, bs and confirmed that the event of cable detaches from handle cannula, sheath kink, sheath separates from handle, inability to function snare loop was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Taking into consideration the evaluation conducted at the complaint investigation site and the details of the complaint, this investigation is assigned the most probable cause classification of adverse event related to procedure.A complaint with a most probable cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: CAPTIFLEX
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9413364
• MDR Text Key: 189758620
• Report Number: 3005099803-2019-05802
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019459
• UDI-Public: 08714729019459
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Model Number: M00562471
• Device Catalogue Number: 6247
• Device Lot Number: 0024173887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1