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

Model Number M00562673

Device Problems Failure to Cut (2587); Difficult to Open or Close (2921)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 12/18/2020

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 medium oval flexible snare was used to remove a target polyp in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the staff were cutting the target polyp with the physician.They tightened the snare around the polyp but the snare would not cut through, he was getting heat but it would not cut.The physician continued to open and close the snare until he would get it to cut through the polyp.Reportedly, no other issues was noted with the device.The procedure was completed with the original device.The patient had bleeding/hematoma caused by the device issue, however, 2 clips were placed to resolve the bleeding.The patient condition following the procedure was reported to be fine.

Manufacturer Narrative

Block h6: problem code a050702 captures the reportable event of snare loop cutting issues.Block h10: investigation results a sensation medium oval flexible snare was received for analysis.Visual inspection of the returned device revealed no issues was noted with the loop.Also, functional inspection was performed and the device was connected to the 10 inch loop fixture and the loop extended and contracted without issues.Additionally, the device passed the continuity test which is 10.1 ohms (the resistance shall be less than 20 ohms), indicating a proper connection.The device passed dimensional inspection.No other issues were noted.Based on the event description, the problem was noticed during procedure and inside the patient.It was unable to confirm the reported event of device difficult to actuate, since there was no issues noted with the actuation of the loop upon return.Also, the reported issue of "loop failure to cut" could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The hemorrhage reported in the complaint is a known potential complication related with the use of the device and it is noted within the instructions for use (ifu).Per continuity test, the device passed since the electrical resistance is within specification of 10.1 ohms (the resistance shall be less than 20 ohms), indicating a proper connection.Moreover, per dimensional inspection of the working length, the result was within specification.Based on the information available and the analysis performed, the most probable root cause classification is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a sensation medium oval flexible snare was used to remove a target polyp in the colon during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the staff were cutting the target polyp with the physician.They tightened the snare around the polyp but the snare would not cut through, he was getting heat but it would not cut.The physician continued to open and close the snare until he would get it to cut through the polyp.Reportedly, no other issues was noted with the device.The procedure was completed with the original device.The patient had bleeding/hematoma caused by the device issue, however, two (2) clips were placed to resolve the bleeding.The patient condition following 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: 11165771
• MDR Text Key: 226796945
• Report Number: 3005099803-2020-06606
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729501664
• UDI-Public: 08714729501664
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2023
• Device Model Number: M00562673
• Device Catalogue Number: 6267-40
• Device Lot Number: 0025916287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1