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

Model Number M00561831

Device Problems Connection Problem (2900); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The initial reporter's address (b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a rotatable medium oval med stiff snare was to be used to remove the target polyp in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the active cord connector failed to connect with the device.Reportedly, the cautery pin was loose and it came off.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be good.

• Brand Name: ROTATABLE SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9647545
• MDR Text Key: 189922956
• Report Number: 3005099803-2020-00193
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283997
• UDI-Public: 08714729283997
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: M00561831
• Device Catalogue Number: 6183
• Device Lot Number: 0024064832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1