MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPTIVATOR; SNARE, FLEXIBLE

Model Number	M00561311
Medical Device Problem Codes	Failure to Cut (2587); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a captivator large oval med stiff snare was used in the colon during a polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare loop was in an irregular shape and the polyp could not be cut.No visible problem was noted with the handle.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a captivator large oval med stiff snare was received for analysis.Visual and microscope inspection of the returned device revealed that the loop was bent/kinked, and the working length was torn in the most distal side.Functional testing was performed, and the loop could extend and retract well.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported event 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 and device passed the electrical test.The reported event of loop bent was confirmed.During visual evaluation of the returned device it was observed that the loop was bent/kinked.It was also observed that the distal side of the working length was torn.It is probable that these problems happened by an excessive force being applied in the device.Most likely procedural factors as handling of the device, the technique used by the physician during initial use, set-up, power-up, or shortly thereafter could have affected its condition.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a captivator large oval med stiff snare was used in the colon during a polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare loop was in an irregular shape and the polyp could not be cut.No visible problem was noted with the handle.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• Brand Name: CAPTIVATOR
• 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: 15487204
• Report Number: 3005099803-2022-05493
• Device Sequence Number: 1958398
• Product Code: FDI
• UDI-Device Identifier: 08714729019251
• UDI-Public: 08714729019251
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 11/30/2024
• Device Model Number: M00561311
• Device Catalogue Number: 6131
• Device Lot Number: 0028479119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 10/30/2022
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 68 KG