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

Model Number	M00562691
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a sensation small oval flexible snare was used during a procedure performed on unknown date.During the procedure and inside the patient, the wire unraveled.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: problem code a0401 captures the reportable event of snare loop break.Block h10: investigation results a sensation small oval flexible snare was received for analysis.Visual and microscope inspection of the returned device revealed that the loop was partially broken.No other device problems were noted.The reported event of loop break was confirmed.During product analysis it was observed that the loop was partially broken.An investigation to address this problem has been completed.The investigation determined that the most assignable cause is human error as it was determined that the product builder did not follow the procedure for inspection of the loop as the defect was not discarded and the unit was sold.The investigation concluded that this is considered an isolated event.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is manufacturing deficiency.
Event or Problem Description
It was reported to boston scientific corporation that a sensation small oval flexible snare was used during a procedure performed on unknown date.During the procedure and inside the patient, the wire unraveled.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
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15174243
• Report Number: 3005099803-2022-04271
• Device Sequence Number: 12042482
• Product Code: FDI
• UDI-Device Identifier: 08714729158158
• UDI-Public: 08714729158158
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 03/21/2025
• Device Model Number: M00562691
• Device Catalogue Number: 6269
• Device Lot Number: 0029083544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown