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

Model Number M00561231

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212); Failure to Cut (2587)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2022-05338 for the associated device information.It was reported to boston scientific corporation that a captivator ii-15mm round stiff snare was used to remove a 4mm polyp during an unknown procedure performed on an unknown date.During the procedure and inside the patient, the snare was initially used cold for the resection of a polyp but it was an ineffective cut and the snare became blocked in the tissue.It was reported that it was difficult to remove the snare from the polyp.There was another attempt to use the same snare cold but it again would not cut.The snare was then tried hot and it would not connect to cautery or cut.The procedure was completed with a non bsc device.The patient had damaged tissue with minor bleeding and a hemostatic clip was used as a precautionary measure.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Problem code a090402 captures the reportable event of snare unable to deliver energy.Problem code a150208 captures the reportable event of snare loop entrapment.Block h10: investigation results; a captivator ii-15mm round stiff snare was received for analysis.Visual inspection of the returned device revealed no problems with the snare and active cord.Functional inspection was performed and when the device was connected to the 10-inch loop fixture, it retracted and extended well.The 2 in 1 connector passed dimensional testing.Electrical test was performed, and the device passed.No other device problems were noted.The reported event of loop unable to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of device unable to deliver energy was not confirmed since the device passed the electrical testing and was found within specification.The reported event of loop entrapment of device or device component could not be confirmed since this event was related to the procedure; therefore, it could not be functionally or visually verified.It is possible that procedural factors led to an entrapment of the device, however this could not be confirmed.Device analysis found no problems with the device during visual and functional testing.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report#: 3005099803-2022-05334 and 3005099803-2022-05338 for the associated device information.It was reported to boston scientific corporation that a captivator ii-15mm round stiff snare was used to remove a 4mm polyp during an unknown procedure performed on an unknown date.During the procedure and inside the patient, the snare was initially used cold for the resection of a polyp but it was an ineffective cut and the snare became blocked in the tissue.It was reported that it was difficult to remove the snare from the polyp.There was another attempt to use the same snare cold but it again would not cut.The snare was then tried hot and it would not connect to cautery or cut.The procedure was completed with a non bsc device.The patient had damaged tissue with minor bleeding and a hemostatic clip was used as a precautionary measure.No further information has been obtained despite good faith efforts.

• Brand Name: CAPTIVATOR II
• 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: 15536613
• MDR Text Key: 306004552
• Report Number: 3005099803-2022-05334
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: 08714729855910
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561231
• Device Catalogue Number: 6123
• Device Lot Number: 0029314464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1