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

Model Number M00562651

Device Problems Retraction Problem (1536); Failure to Cut (2587); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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 to be used in the colon during a polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, when closing the forceps during polypectomy, the forceps made an unusual clicking noise and the system lifted off the rail.In addition to total closure, the system did not respond properly and it was more difficult to cut the polyp.Additionally, the cautery pin was noted to have visible damage.The procedure was completed with another sensation short throw.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date of (b)(6) 2021 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: problem code a050702 captures the reportable event of snare loop cutting issue.Block h10: investigation results: a sensation large oval med stiff snare was received for analysis.Visual inspection of the returned device revealed no issues were noted along the device.During functional evaluation, the device was connected to the 10 inch loop fixture and the snare loop extended and contracted without issues.Continuity test was performed and the device passed, indicating a proper connection.No other issues were noted.The reported event of "loop failure to cut" was not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of "loop retraction problem" was unable to be confirmed since the loop retracted without issue upon return.The reported event of "cautery pin bent and handle cannula bent" were unable to be confirmed since no bent was noted in the cautery and cannula upon return.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device during visual and functional test.No issues were noted with the electrical device testing during continuity test.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a sensation large oval med stiff snare was to be used in the colon during a polypectomy procedure performed on an unknown date.It was reported that during the procedure and inside the patient, when closing the forceps during polypectomy, the forceps made an unusual clicking noise and the system lifted off the rail.In addition to total closure, the system did not respond properly and it was more difficult to cut the polyp.Additionally, the cautery pin was noted to have visible damage.The procedure was completed with another sensation short throw.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: SENSATION SHORT THROW
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12087591
• MDR Text Key: 259146326
• Report Number: 3005099803-2021-03054
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729158110
• UDI-Public: 08714729158110
• Combination Product (y/n): N
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

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: 07/23/2023
• Device Model Number: M00562651
• Device Catalogue Number: 6265
• Device Lot Number: 0025761137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1