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

Model Number M00562671

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: visual evaluation of the returned device revealed that the active cord connector was broken.Functional test was performed and the device extends and retracts within specification.In addition, the device was also submitted to material testing and the device presented a mechanical overload with torsion and final tension component as a failure mode.Based on the information available and the analysis performed, it is most likely that operational factors, such as user technique, handling or manipulation during procedure, contributed to the broken condition of the active cord connector, therefore the most probable cause to the failure found is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a sensation medium oval flexible snare was used in the stomach during a gastric polyp removal performed on (b)(6) 2019.According to the complainant, during the procedure, when the device was delivered to the lesion and connected to the knife, it was noted that the connection between the wire inside the catheter and snare loop was fractured.However, the snare loop itself was intact.The procedure was completed with another sensation snare.There were no patient complications reported as a result of this event.The patient condition at the conclusion of 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 cautery pin 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: 8959604
• MDR Text Key: 156450067
• Report Number: 3005099803-2019-04233
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158141
• UDI-Public: 08714729158141
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131700
• 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: 09/04/2019

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: 09/11/2021
• Device Model Number: M00562671
• Device Catalogue Number: 6267
• Device Lot Number: 0022645556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• 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
• Patient Age: 48 YR
• Patient Weight: 52