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

Model Number M00562451

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of cautery pin detached.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used during a mucosal resection procedure performed on an unknown date.During the procedure, the captivator snare was utilized while holding it down since the cautery pin would fall off the device.The procedure was completed with another captivator small hexagonal stiff snare.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used during a mucosal resection procedure performed on an unknown date.During the procedure, the captivator snare was utilized while holding it down since the cautery pin would fall off the device.The procedure was completed with another captivator small hexagonal stiff snare.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: imdrf device code a0501 captures the reportable event of cautery pin detached.Block h10: the returned captivator small hexagonal stiff snare was analyzed, and a visual evaluation was performed, and it was determined that no damages were present on the device.Additionally, the 2-1 connector was found to be correctly attached.The reported event was not confirmed.Based on all available information, the device was carefully examined, and no damages were observed.The 2-1 connector was found to be properly attached, indicating that the device was in a functional state.Based on this evidence and the absence of any observable defects, the reported complaint cannot be confirmed.Therefore, the event is classified as "no problem detected.".

• 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 CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16934833
• MDR Text Key: 315300414
• Report Number: 3005099803-2023-02537
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: 08714729071068
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131700
• 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,Followup
• Report Date: 06/29/2023

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: M00562451
• Device Catalogue Number: 6245
• Device Lot Number: 0029947286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 06/07/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2022
• 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