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

Model Number	M00560321
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported to boston scientific corporation that a sensation small oval med stiff snare was used in the rectum during a colon endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.During the procedure and inside the patient, the device was unable to cauterized a 10mm lesion.The high frequency device and adapter were checked; however, there were no issues noted.The cauterization was attempted again but it was unable to excise the target polyp, the procedure was completed with a completely different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code a050702 captures the reportable event of loop resecting issue.Block h10: (product investigation): one sensation snare was received for analysis.Visual inspection of the returned device revealed that the device did not have any defective condition.Functional evaluation of the returned device found that when the device was connected to the 10 inch loop fixture and the loop extended and contracted without issues.Continuity test was performed and the device's electrical resistance was within specification, indicating a proper connection.Based on the evaluation of the complaint device, it was unable to confirm the reported event of "device failure to deliver energy" since no issues were noted with the electrical device testing during continuity test upon return.The reported issue of "loop failure to cut" could not be confirmed since the devices cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Device analysis found no issues with the device during visual and functional test.No issues were noted with the electrical device testing during continuity test.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is no problem detected.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 or Problem Description
It was reported to boston scientific corporation that a sensation small oval med stiff snare was used in the rectum during a colon endoscopic mucosal resection (emr) procedure performed on (b)(6) 2021.During the procedure and inside the patient, the device was unable to cauterized a 10mm lesion.The high frequency device and adapter were checked; however, there were no issues noted.The cauterization was attempted again but it was unable to excise the target polyp, the procedure was completed with a completely different device.There were no patient complications reported as a result of this event.

• Brand Name: SENSATION SHORT THROW
• Common Device Name: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12091703
• Report Number: 3005099803-2021-03052
• Device Sequence Number: 17133739
• Product Code: FDI
• UDI-Device Identifier: 08714729283928
• UDI-Public: 08714729283928
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: M00560321
• Device Catalogue Number: 6032
• Device Lot Number: 0026002850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1