MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSATION SHORT THROW; SNARE, FLEXIBLE

Model Number M00562652

Device Problem Failure to Cut (2587)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date of (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the device lot number.Therefore, the manufacture, and expiration dates are unknown.(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 sensation large oval med stiff snare was used during an unknown procedure performed on an unknown date.According to the complainant, during the procedure, they were having issues with the snare not cutting properly.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: SENSATION SHORT THROW
• 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.; 256 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10733970
• MDR Text Key: 213015101
• Report Number: 3005099803-2020-04847
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729268802
• UDI-Public: 08714729268802
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562652
• Device Catalogue Number: 6265-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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