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

Model Number	M00562341
Medical Device Problem Codes	Mechanical Problem (1384); Retraction Problem (1536); Failure to Cut (2587); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of four devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-05820, 3005099803-2022-05828, 3005099803-2022-05829 for the associated device information.It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a 6cm polyp in the cecum during a colonoscopy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snares were losing shape after minimal use.The snare loop came out twisted and was not responsive to opening and closing movements.They attempted to cut the target polyp before it had a problem with extension but due to the snare loops condition, the device was unable to cut the polyp.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.
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).
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.Block h11: blocks b5 and h6 device code has been corrected.This report was sent in error.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.
Event or Problem Description
It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a 6cm polyp in the cecum during a colonoscopy procedure performed on (b)(6) 2022.During the procedure and inside the patient, the snare loop shape was not maintained after two uses.The snare loop came out crossed/twisted.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.Correction october 11, 2022: this report was sent in error.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.

• 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: 15579381
• Report Number: 3005099803-2022-05830
• Device Sequence Number: 6385446
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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 Model Number: M00562341
• Device Catalogue Number: 6234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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