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

Model Number M00561821

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

Device problem code captures the reportable event of cautery pin detachment.The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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

This report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used during a procedure performed on (b)(6) 2018.According to the complainant, it was noticed that the cautery pin connection was loose and would came off easily.A second device was used and the same issue occured.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used during a procedure performed on (b)(6) 2018.According to the complainant, it was noticed that the cautery pin connection was loose and would came off easily.A second device was used and the same issue occured.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Device problem code 2907 captures the reportable event of cautery pin detachment.Investigation results: visual evaluation of the returned device found that the device does not have any visual failure, the pin gage is in good condition.Dimensional evaluation was performed and the device passed the go/no go cord gage test.Based on the information available and the analysis performed, the most probable root cause is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 8101820
• MDR Text Key: 128277742
• Report Number: 3005099803-2018-61577
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0022537673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2018
• Date Manufacturer Received: 12/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1