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

Model Number M00562673

Device Problems Retraction Problem (1536); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.The initial reporter for this complaint was the physician.However, the physicain name and contact information are unknown.(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 medium oval med stiff snare was used during a colonoscopy with polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the endoscopist was using a sensation medium oval snare to remove a polyp, however, they experienced issues in closing the snare and cutting the tissue.The nurse manager came in the room to help the technician but they experienced the same issue.They tried it in the next three (3) procedures and the same issue kept occuring, therefore, they refused to use the snares moving forward.Although the procedure was completed, it was not reported how the procedure was completed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Event Description

It was reported to boston scientific corporation that a sensation medium oval med stiff snare was used during a colonoscopy with polypectomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the endoscopist was using a sensation medium oval snare to remove a polyp, however, they experienced issues in closing the snare and cutting the tissue.The nurse manager came in the room to help the technician but they experienced the same issue.They tried it in the next three (3) procedures and the same issue kept occuring, therefore, they refused to use the snares moving forward.Although the procedure was completed, it was not reported how the procedure was completed.There were no patient complications reported as a result of this event.***additional information received on august 18, 2020 and august 20, 2020*** the reported upn m00560310 did not match with lot# 25255683.However, upon product search, lot# 25255683 matched with upn m00562673 for a sensation medium oval flexible snare.Therefore upn m00562673 - sensation medium oval flexible snare was used to capture this complaint.These four sensation snares were used for multiple cases and multiple patients to remove a polyp in the large colon.The problem occured inside the patient.Reportedly, these four (4) snares were securely attached to the active cord and there were no visible issues noted with the cautery pins of these four (4) devices.The devices were all tested before use in the patients by simple opening and closing of the snares.Reportedly, all these four (4) devices were able to retract after they were removed from the scope/patient but the devices did not retract through the tissue.The procedures were completed with a completely different snare.The patient condition following the procedure was reported to be fine.

Manufacturer Narrative

Block e1: the initial reporter for this complaint was the physician.However, the physicain name and contact information are unknown.Block h6: problem code 2587 captures the reportable event of snare loop failed to cut.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.Block h11: blocks b5 and h2 have been updated based on the additional information received on august 18, 2020 and august 20, 2020.Blocks h6 (evaluation conclusion codes) and h10 have been updated based on the investigation closure for device not returned.Blocks d4, h4 and h10 have been corrected.

• 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: 10416219
• MDR Text Key: 203841286
• Report Number: 3005099803-2020-03334
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729283904
• UDI-Public: 08714729283904
• 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: 09/09/2020

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: 02/24/2023
• Device Model Number: M00562673
• Device Catalogue Number: 6267-40
• Device Lot Number: 0025255683
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1