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

Model Number M00561821

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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 rotatable small oval med stiff snare was used during a colorectal polypectomy performed on an unknown date.According to the complainant, during the procedure, the physician tried to use the device and plugged the cord, but it could not be connected.Upon checking, the cautery pin was noted to be detached/separated and it was included separately in the bag therefore it was reported to be defective.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Block h6: problem code 2907 captures the reportable event of cautery pin detached/separated.Block h10: visual analysis of the returned device revealed that the cautery pin was detached.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.There is an investigation in place to address this issue.A review of the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used during a colorectal polypectomy performed on an unkown date.According to the complainant, during the procedure, the physician tried to use the device and plugged the cord, but it could not be connected.Upon checking, the cautery pin was noted to be detached/separated and it was included separately in the bag therefore it was reported to be defective.There were no patient complications reported as a result of this event.

• Brand Name: ROTATABLE SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8671086
• MDR Text Key: 147173072
• Report Number: 3005099803-2019-02725
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: 08714729283980
• Combination Product (y/n): N
• PMA/PMN Number: K160637
• 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: 07/18/2019

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: 01/25/2022
• Device Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0023246919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1