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

Model Number M00562651

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

(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 2 in 1 connector and the handle cannula was detached.It is most likely that this condition contributed to the failure of delivering energy and this led to difficulties in cutting tissue.No other issues were noted.Since the device has the 2 in 1 connector and the handle cannula detached, these suggest that the assembly process was not performed as per procedure.Based on the information available and the analysis performed, the most probable root cause classification is manufacturing deficiency.A review of the potential causes and controls of the related failure was completed.Based on this review, this complaint does not represent a new or unanticipated event.A labelling review was performed and there was no evidence that the device was used in a manner inconsistent with the labeling or that suggests that there is an issue with the translation, wording, or graphics.There is an investigation in place to address this issue.

Event Description

It was reported to boston scientific corporation that a sensation large oval med stiff snare was prepared for use in the rectum during an endoscopic mucosal resection (emr) procedure on (b)(6), 2019.According to the complainant, when the device entered the cargo inspection channel and inside the patient, the device failed to deliver energy upon opening, so it failed to cut the target polyp.Reportedly, there were no visible issues noted with the cautery pin and the snare was securely attached to the active cord.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: 9179071
• MDR Text Key: 173215569
• Report Number: 3005099803-2019-04776
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158110
• UDI-Public: 08714729158110
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2021
• Device Model Number: M00562651
• Device Catalogue Number: 6265
• Device Lot Number: 0021813903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2018
• 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: 53 YR
• Patient Weight: 56