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

Model Number M00561231

Device Problem Failure to Cut (2587)

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

Event Date 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: a captivator ii-15mm round stiff snare was received for analysis.Visual and microscope inspection of the returned device revealed no problems noted.Functional inspection was performed and when the device was connected to the 10-inch loop fixture, it contracted and extended well.Media inspection of the photo provided by the customer revealed that the device inside the pouch and no problems were noted.No other device problems were noted.The reported complaint of loop failure to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Device analysis found no problems with the device during visual and functional test.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected since the complaint cannot be confirmed.

Event Description

It was reported to boston scientific corporation that a captivator ii-15mm round stiff snare was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure and inside the patient, multiple polyps were discovered.The first polyp was larger about 15-20mm, and the doctor used hot snaring to remove the polyp.The next polyps were smaller, and the physician attempted cold snaring, but it wouldn't cut through the polyps.The procedure was completed with the same device using hot snaring.There were no patient complications reported as a result of this event.

• 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: 15909052
• MDR Text Key: 307922463
• Report Number: 3005099803-2022-06993
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729855910
• UDI-Public: 08714729855910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133987
• 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
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• 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: 0029537353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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
• Patient Age: 51 YR
• Patient Sex: Female