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

Model Number M00562321

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 09/08/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the snare fractured directly after it was unpacked.The procedure was completed with another new snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: the reported (b)(6) health care facility.The reported health care facility's address is equipment section(b)(6).Block h6: imdrf device code a0401 captures the reportable event of snare loop break.

Manufacturer Narrative

Block e1: the reported health care facility is yagami seisakusho co., ltd.Tokai product control center.The reported health care facility's address is(b)(6).Block h11: block b5 was updated to include additional information received on november 14, 2023.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 snare was used during a colonoscopy procedure performed on (b)(6) 2023.During the procedure, the snare fractured directly after it was unpacked.The procedure was completed with another new snare.There were no patient complications reported as a result of this event.Additional information received on november 14, 2023* the sheath was broken, and it happened outside the patient.

• 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: 18105671
• MDR Text Key: 327781488
• Report Number: 3005099803-2023-06140
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0030121658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2022
• 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