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

Model Number M00562651

Device Problems Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The initial reporter's address is (b)(6).(b)(4).Investigation results: a sensation large oval med stiff snare was received for analysis.Visual inspection of the returned device revealed that the handle cannula and the 2 in 1 pin connector was detached.Functional inspection was not performed due to the device condition.No other issues were noted.Based on the event description, the problem was noticed during procedure.It was initially reported that when trying to open and close the snare, it was unable to open and close properly.However, an evaluation of the device was executed and concluded that the handle cannula detached issue was caused due to the thread in the 2 in 1 connector which caused that the cannula was partially secured to the active cord insertion during the screwing process.Based on the information available and the analysis performed, the most probable root cause classification is cause traced to component failure.There is an investigation in place to address this issue.The investigation has not identified a potential process or design related issue for the batch number, further review at batch level is not required at this time.Emerging trends are captured as part of the post market signal evaluation and escalation process.A risk review of the sensation snares was completed using the snare family global design fmea, bsc, bv, and confirmed that the event of "device-difficult to actuated", "device-handle cannula- detached/separated" and "snare- pin-detached/separated" were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.The complaint type does not present a new or unanticipated failure type or harm per risk management document.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

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 (b)(6) 2020.According to the complainant, during the procedure, when trying to open and close the snare, it was unable to open and close properly so verification was requested.Reportedly, no other issues was noted with this device and the instructions were followed during preparation.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the 2 in 1 connector was detached.

• 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.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10651225
• MDR Text Key: 210633466
• Report Number: 3005099803-2020-04440
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158110
• UDI-Public: 08714729158110
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2023
• Device Model Number: M00562651
• Device Catalogue Number: 6265
• Device Lot Number: 0025072619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• 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