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

Model Number M00562451

Device Problems Failure to Cut (2587); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

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 captivator small hexagonal stiff snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the handle of the snare was crooked and it was not possible to remove the polyp.The device was removed and the procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: problem code 2587 captures the reportable event of snare loop failed to cut.Block h10: investigation results a captivator small hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed that the device had the cap connector detached, and due to this condition, the device was unable to extend and retract the loop.Therefore, the reported issue of "loop failure to cut" was confirmed.Also, the device was carefully inspected and the loop was bent.During continuity test, the device passed since the device's electrical resistance is within specification: 10.1 ohms (the resistance shall be less than 20 ohms), indicating a proper connection.No other issues were noted.Based on the event description, the problem was noticed during procedure and inside the patient.It was noted that the cap connector was detached from the handle which were not mentioned in the complaint report and the source of this problem encountered is unknown.Additionally, upon product analysis, it was noted that the snare loop was bent which was not also mentioned in the complaint report and which most likely occurred as a result of procedure handling or re-packaging of the device.Based on the information available and the analysis performed, the most probable root cause classification is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the handle of the snare was crooked and it was not possible to remove the polyp.The device was removed and the procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: CAPTIVATOR
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10581916
• MDR Text Key: 208751636
• Report Number: 3005099803-2020-04073
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: 08714729071068
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2022
• Device Model Number: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0024955531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 70