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

Model Number M00562301

Device Problems Failure to Deliver Energy (1211); Failure to Cut (2587); Device-Device Incompatibility (2919)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-05554 and for the associated device information.It was reported to boston scientific corporation that a captivator small oval stiff snare was prepared for use during a colonoscopy procedure performed on an unknown date.During preparation, the beamer cord was very difficult to hook into the connector.They were able to get the cord connected but it required a lot of pressure and twisting to get it attached.It was reported that the tech thought the cord was connected but it was not and they ended up cold snaring.The procedure was completed with a non-bsc product.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Event date: approximated based on the date the manufacturer became aware of the event.(b)(4).

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-05554 and 3005099803-2022-05555 for the associated device information.It was reported to boston scientific corporation that a captivator small oval stiff snare was prepared for use during a colonoscopy procedure performed on an unknown date.During preparation, the beamer cord was very difficult to hook into the connector.They were able to get the cord connected but it required a lot of pressure and twisting to get it attached.It was reported that the tech thought the cord was connected but it was not and they ended up cold snaring.The procedure was completed with a non-bsc product.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: problem code a090402 captures the reportable event of snare unable to deliver energy.Problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a captivator medium hexagonal stiff snare was received for analysis.Visual inspection of the returned device revealed no problems were found.Microscope inspection noted some marks of friction on the 2 in1 connector, probably by the interaction with the active cord.Functional testing was performed, and the loop could extend and retract well.The device was tested with a boston scientific active cord and the device connected well.Additionally, the device was plugged in with a non-bsc active cord, however, the device connected well.Finally, the device was plugged in with another non-bsc active cord and the device connected well.During dimensional testing it was noted that the internal gap dimension of the 2 in 1 connector was not according to the referenced drawing.Electrical testing was performed, and the device was found within specification.No other problems were noted.The reported complaint of device failure to deliver energy was unable to be confirmed since the device passed electrical testing upon return.In addition, the 2 in 1 connector had some marks of friction probably by the same force applied to attach the handle to the active cord.The reported complaint of loop failure to cut was not confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.The reported event of device interaction with another device was confirmed.During dimensional analysis it was noted that some measurements of the 2 in 1 connector were not as expected.An investigation to address this problem is in progress.Based on the analysis of the returned device and the information available, the most probable cause is manufacturing deficiency.

• 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: 15536601
• MDR Text Key: 306323402
• Report Number: 3005099803-2022-05555
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019312
• UDI-Public: 08714729019312
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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: M00562301
• Device Catalogue Number: 6230
• Device Lot Number: 0029801649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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