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

Model Number M00561820

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was to be used during a colonoscopy procedure on (b)(6) 2019.According to the complainant, during the procedure and outside the patient, when they took the device out of the package and went to connect the cautery cord, they realized that there was no metal piece in the middle.They looked inside the bag and saw that the cautery pin had fallen off and was disconnected from the device.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Problem code 2907 captures the reportable event of cautery pin detachment.Investigation results: a rotatable snare was received for analysis.Visual evaluation of the returned device revealed that the device has the active cord connector detached.Based on the information available and the analysis performed, the most probable root cause for this problem is manufacturing deficiency due to problems traced to manufacturing process.There is an investigation in place to address this issue.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was to be used during a colonoscopy procedure on (b)(6) 2019.According to the complainant, during the procedure and outside the patient, when they took the device out of the package and went to connect the cautery cord, they realized that there was no metal piece in the middle.They looked inside the bag and saw that the cautery pin had fallen off and was disconnected from the device.The procedure was completed with another rotatable snare.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: 9110298
• MDR Text Key: 159962019
• Report Number: 3005099803-2019-04423
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729747703
• UDI-Public: 08714729747703
• Combination Product (y/n): N
• PMA/PMN Number: K992477
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2021
• Device Model Number: M00561820
• Device Catalogue Number: 6182S
• Device Lot Number: 0022961490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1