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

Model Number M00562341

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Failure to Cut (2587); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  malfunction  

Event 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.

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).

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 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
• Type of Device: 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
• MDR Text Key: 306993073
• Report Number: 3005099803-2022-05830
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019350
• UDI-Public: 08714729019350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M00562341
• Device Catalogue Number: 6234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1