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

Model Number M00561221

Device Problem Break (1069)

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

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation results: a captivator ii-10mm round stiff snare was received for analysis.Visual inspection of the returned device revealed no problems; however, a plastic bag was returned with a foreign material.In addition, per microscopic and other inspection, a sem-eds analysis was performed and determined that the returned foreign material was a human hair.Functional inspection was performed and when the device was connected to the 10-inch loop fixture, it could extend and retract well.No other problems were noted.The reported event was not confirmed.Per product analysis, the customer provided a picture, and it showed that the device was inside the patient.Additionally, a plastic bag was returned and attached to it was a pouch containing a foreign material which was determined to be a human hair.There is no control over how the devices are handled/manipulated in the field, it is possible that the foreign material was present during the procedure, during the preparation or manipulation of the device.Therefore, 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-10mm round stiff snare was used to remove polyps in the colon during a polypectomy procedure performed on (b)(6) 2022.During the procedure and inside the patient, there was a stainless material at the front tip of the snare.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: this event has been deemed a reportable event based on the investigation finding of foreign material present on device.

• 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: 16067321
• MDR Text Key: 306655875
• Report Number: 3005099803-2022-07742
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Physician
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561221
• Device Catalogue Number: 6122
• Device Lot Number: 0029069469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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