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

Model Number M00560331

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned sensation short throw was analyzed, and a visual evaluation noted that the loop was broken with evidence of a burned wire.The working length was measured and was found to be within specification.No other visual failures were noted.The investigation findings revealed the loop was broken, consequently confirming the reported event "wire broke".The investigation concluded that the observed failure was likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated and/or the technique used by the physician during initial use of set-up or power-up, limited the performance of the device and contributed to the broken loop.Additionally, the broken loop may occur due to an excessive application of power during the cauterization process; the loop may overheat causing it to break.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a sensation short throw was used during a procedure performed on (b)(6) 2020.According to the complainant, during preparation, the wire broke off when the snare handle was manipulated before the procedure.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10952589
• MDR Text Key: 226643821
• Report Number: 3005099803-2020-05923
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283935
• UDI-Public: 08714729283935
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2022
• Device Model Number: M00560331
• Device Catalogue Number: 6033
• Device Lot Number: 0024262000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2019
• 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