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

Model Number M00562670

Device Problems Break (1069); Entrapment of Device (1212); Mechanical Problem (1384); Retraction Problem (1536); Difficult to Open or Close (2921); Material Twisted/Bent (2981)

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

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a sensaton medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the physician tried to resect the less than 1cm target polyp, and when the snare was almost completely closed the handle would not move any further.There was extreme resistance and they tried to open the snare to reposition.The snare would not open.The snare was around the target polyp too tightly to remove.The physician applied more force to try to close the snare.The physician squeezed the handle to close as hard as possible and the handle broke and the handle cannula was bent.The physician then yanked on the catheter and the polyp was ripped from the submucosal and the polyp and snare were removed from the patient.The procedure was completed with this device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: problem code a150208 captures the reportable event of loop embedded in patient's tissue.Block h10: (product investigation) one sensation snare was received for analysis.Visual evaluation of the returned device found that the finger ring, cannula and peek tubing were exiting the handle of the device.In addition, the cannula, working length in the middle section and peek tubing were kinked.Microscope evaluation of the returned device found that the snare finger ring had evidence of deformation at distal end of it, where the cannula is inserted with the wire.The reported event of "loop entrapment of device or device component" could not be confirmed since the devices cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported events of "device difficult to actuate," "loop retraction problem," "loop failure to extend," "handle cannula bent" and "handle break" were confirmed.During product analysis it was observed that the finger ring, cannula and peek tubing were exiting the handle of the device, which is likely what the customer perceived as "handle cannula break." also, the cannula, working length at the middle section and peek tubing were noted kinked.Under microscope magnification the snare finger ring was verified and had evidence of deformation at the distal end of it where the cannula is inserted with the wire, which may occur when the catheter/wire is kinked; the friction between the wire and the catheter causes difficulty actuating and eventually, the cannula exits from the finger ring and the device is unable to extend or retract the loop.These device problems most likely occurred as a result of application of excessive force during handling or usage.Forcing the device against significant resistance could result in damage to the sensation snare resulting in a loss of functionality.The product record review confirmed that this is not a new failure type and the risk is anticipated.There is no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Based on the information available and the analysis performed, the most probable root cause for this problem is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.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 sensaton medium oval flexible snare was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the physician tried to resect the less than 1cm target polyp, and when the snare was almost completely closed the handle would not move any further.There was extreme resistance and they tried to open the snare to reposition.The snare would not open.The snare was around the target polyp too tightly to remove.The physician applied more force to try to close the snare.The physician squeezed the handle to close as hard as possible and the handle broke and the handle cannula was bent.The physician then yanked on the catheter and the polyp was ripped from the submucosal and the polyp and snare were removed from the patient.The procedure was completed with this device.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
• MDR Report Key: 12394252
• MDR Text Key: 269271959
• Report Number: 3005099803-2021-04364
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729748083
• UDI-Public: 08714729748083
• Combination Product (y/n): N
• PMA/PMN Number: K941750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2024
• Device Model Number: M00562670
• Device Catalogue Number: 6267S
• Device Lot Number: 0026840670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1