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

Model Number	M00560301
Medical Device Problem Codes	Failure to Deliver Energy (1211); Entrapment of Device (1212); Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a sensation large oval med stiff snare was used in the rectal sigmoid during a colonoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, while trying to cauterize a large polyp, it was noticed that the snare was defective.The device failed to deliver energy and the snare loop would not extend.The snare was then cut and was safely removed from the patient.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 satisfactory.

• 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: 9371090
• Report Number: 3005099803-2019-05614
• Device Sequence Number: 3229894
• Product Code: FDI
• UDI-Device Identifier: 08714729283898
• UDI-Public: 08714729283898
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00560301
• Device Catalogue Number: 6030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention