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

Model Number	M00560321
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 short throw was used during an intestinal polyps removal procedure performed on (b)(6) 2021.During preparation, the physician unpacked the device but found that the position of the coil and the woven rope became loose, leading the diameter of the coil to become larger.The coil deformed.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code a0401 captures the reportable event of loop break.Block h10: the returned sensation short throw was analyzed, and a visual evaluation did not identify any problems and noted that the loop was within specification.A functional evaluation was done and the device was connected to the 10 inch loop fixture and the loop extended and contracted without issues.A continuity test was done and the device passed since the device's electrical resistance was within specification, indicating a proper connection.No other problems with the device were noted.The reported event of loop break could not be confirmed since no problems were noted with the loop upon visual and functional testing and the device passed the continuity test upon return.The product record review confirmed that this is not a new failure type and the risk is anticipated.There was no evidence of a manufacturing issue, design or user issue which could have caused the complaint.Based on the information available and the analysis of the returned device, the code selected as the most probable complaint cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a sensation short throw was used during an intestinal polyps removal procedure performed on (b)(6) 2021.During preparation, the physician unpacked the device but found that the position of the coil and the woven rope became loose, leading the diameter of the coil to become larger.The coil deformed.The procedure was completed with another sensation short throw.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 11474366
• Report Number: 3005099803-2021-00985
• Device Sequence Number: 3876691
• Product Code: FDI
• UDI-Device Identifier: 08714729283928
• UDI-Public: 08714729283928
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/14/2021

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: 02/20/2023
• Device Model Number: M00560321
• Device Catalogue Number: 6032
• Device Lot Number: 0025241655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 02/20/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 59