MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTATABLE SNARE; SNARE, FLEXIBLE

Model Number M00561821

Device Problems Break (1069); Entrapment of Device (1212); Mechanical Problem (1384); Retraction Problem (1536); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

(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 rotatable small oval med stiff snare was used during a colonoscopy with polypectomy procedure on (b)(6) 2019.According to the complainant, during the procedure and inside the patient, they were attempting to perform polypectomy and when they passed the snare down the colonoscope and put it in the colon, they successfully positioned the snare and captured the 6-7mm sessile polyp.The snare partially closed and became embedded in the patient tissue.The device was pulled from the scope in a closed position and the snare was successfully removed from the polyp.Upon removal of the snare from the end of the scope, they noticed that the handle would no longer work and it would not extend or retract anymore.It seems that the pull wire got disconnected from the catheter handle.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used during a colonoscopy with polypectomy procedure on (b)(6) 2019.According to the complainant, during the procedure and inside the patient, they were attempting to perform polypectomy and when they passed the snare down the colonoscope and put it in the colon, they successfully positioned the snare and captured the 6-7mm sessile polyp.The snare partially closed and became embedded in the patient tissue.The device was pulled from the scope in a closed position and the snare was successfully removed from the polyp.Upon removal of the snare from the end of the scope, they noticed that the handle would no longer work and it would not extend or retract anymore.It seems that the pull wire got disconnected from the catheter handle.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.***additional information received on (b)(6) 2019*** reportedly, the handle cannula was broken.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 1212 captures the reportable event of snare loop entrapment.Block h10: the device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: block b5 have been updated based on the additional information received on (b)(6) 2019.Block h6 (device code) has been corrected based on further review of event description.

Event Description

It was reported to boston scientific corporation that a rotatable small oval med stiff snare was used during a colonoscopy with polypectomy procedure on (b)(6), 2019.According to the complainant, during the procedure and inside the patient, they were attempting to perform polypectomy and when they passed the snare down the colonoscope and put it in the colon, they successfully positioned the snare and captured the 6-7mm sessile polyp.The snare partially closed and became embedded in the patient tissue.The device was pulled from the scope in a closed position and the snare was successfully removed from the polyp.Upon removal of the snare from the end of the scope, they noticed that the handle would no longer work and it would not extend or retract anymore.It seems that the pull wire got disconnected from the catheter handle.The procedure was completed with another rotatable snare.There were no patient complications reported as a result of this event.***additional information received on (b)(6) 2019*** reportedly, the handle cannula was broken.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 1212 captures the reportable event of snare loop entrapment.Block h10: investigation results a rotatable small oval med stiff snare was received for analysis.Visual evaluation of the returned device revealed that the strain relief was kinked near the handle section and the internal wire of the catheter was kinked at same section.In addition, the working length was detached as a result of the cannula hitting against the inner wall.However, the flare was found in good conditions.Finally, kinks in the catheter and wire were noted in the middle section of the catheter.Upon functional evaluation, the device failed to extend the loop and it was difficult to actuate due to the condition of the device.No other issues were noted.It's important to mention that the reported allegation of loop entrapment of device or device component was related to the inability to actuate the handle since the event summary states: ".It was stuck in a closed position and they were able to get the snare off of the polyp." additionally, it was reported that the snare failed to extend from the catheter and the handle was broken.Upon product analysis the failure reported was confirmed since it was unable to extend the device due to the returned condition of the device (strain relief bent).However, it was unable to confirm the failure reported of handle break since the handle was not broken upon return.Based on the event description, the problem was noticed during procedure.It was most likely that during procedure while the device was being manipulated, the failures were generated.The anatomical factors were encountered during the procedure which lead to the detached condition of the sheath and several kinks in the catheter and wire.These kinks offer resistance when the handle was actuated and cause the detached condition which contributed directly to the performance of the loop to extend.Due to the techniques applied or procedural factors, it could have affected the device performance and its integrity, resulting on the catheter condition found.Additionally, during the manufacturing process the units are inspected as per procedure in order to detect bends in the catheter.Based on the information available and the analysis performed, the most probable root cause classification is adverse event related to procedure.A risk review of the rotatable - snares was completed using 90121418, rotatable snare risk analysis workbook, bsc, aw and confirmed that the events of device fails to open, unable to excise polyp and unable to retract snare loop were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• Brand Name: ROTATABLE SNARE
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9535934
• MDR Text Key: 190820831
• Report Number: 3005099803-2019-06347
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283980
• UDI-Public: 08714729283980
• Combination Product (y/n): N
• PMA/PMN Number: K160637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: M00561821
• Device Catalogue Number: 6182
• Device Lot Number: 0024416064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1