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

Model Number M00561821

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

The initial reporter's address is (b)(6).(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 prepared for use during an unknown procedure on (b)(6) 2019.According to the complainant, during preparation and outside the patient, when the device was checked before unpacking, a foreign object like hair was found.They did not open the device and it was not used.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was prepared for use during an unknown procedure on (b)(6) 2019.According to the complainant, during preparation and outside the patient, when the device was checked before unpacking, a foreign object like hair was found.They did not open the device and it was not used.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: the initial reporter's address is (b)(6).Block h6: problem code 2944 captures the reportable event of foreign material present in device.Block h10: a rotatable snare was received for analysis.Visual evaluation of the returned device revealed that the device has a hair inside the sealed package.Due to the hair was found inside the sealed package, this suggests that the manufacturing process was not correctly performed, as per snares packaging, bsc, cm.Procedure.A risk review of the rotatable snare was completed using rotatable snare risk analysis workbook, bsc, au and confirmed that the event of foreign matter inside pouch 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.Based on the information available and the analysis performed, the most probable root cause for this problem is manufacturing deficiency.An investigation was opened to address this issue.

• 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: 9401789
• MDR Text Key: 189754158
• Report Number: 3005099803-2019-05816
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0024416064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1