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

Model Number M00562693

Device Problems Retraction Problem (1536); Failure to Cut (2587); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

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 sensation small oval flexible snare was used in the colon of a male patient for screening a polyp during a colonoscopy with polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the physician attempted to use the snare multiple times.During the second pass, when the physician used the snare, it would not retract into the catheter and it failed cut the target polyp.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 okay.

Manufacturer Narrative

Block h6: problem code 2587 captures the reportable event of snare loop failed to cut.Problem code 2907 captures the reportable failure based on product investigation results of cautery pin detached.Block h10: investigation results a sensation snare was received for analysis.Visual inspection of the returned device revealed that the handle cannula and the 2 in 1 connector were detached.Functional inspection was not performed due to the device condition.No other issues were noted.Based on the event description, the problem was noticed during procedure and inside the patient.An evaluation was executed and concluded that the handle cannula detached issue was caused due to the thread in the 2 in 1 connector and due to this the cannula was partially secured to the active cord insertion during the screwing process.Due to these failures, the loop was unable to retract and cut the polyp.Based on the information available and the analysis performed, the most probable root cause classification is cause traced to component failure.There is an investigation in place to address this issue.A risk review of the sensation - snares was completed using the snare family global design fmea, bsc, bv and confirmed that the event of "snare-loop-failure-to-cut" and "snare-loop-retraction problem " were defined in the risk documentation.This event type has 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 at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a sensation small oval flexible snare was used in the colon of a male patient for screening a polyp during a colonoscopy with polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the physician attempted to use the snare multiple times.During the second pass, when the physician used the snare, it would not retract into the catheter and it failed cut the target polyp.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 okay.

• 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: 10396449
• MDR Text Key: 202619588
• Report Number: 3005099803-2020-03278
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501671
• UDI-Public: 08714729501671
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

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: 11/10/2022
• Device Model Number: M00562693
• Device Catalogue Number: 6269-40
• Device Lot Number: 0024751265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1