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

Model Number M00562451

Device Problem Break (1069)

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

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used to remove a target polyp in the colon during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the snare loop was darkened and looked burnt after using cautery.The photo of the complaint device showed that the snare loop was broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration dates are unknown.Block h6: problem code a0401 captures the reportable event of snare loop broken.Block h10: (product investigation): one captivator snare was received for analysis.Visual and media analysis of the returned device revealed that the loop was broken and blackened/burnt.In addition, the sheath has evidence of residues from the procedure.Electrical testing was also performed and the device's electrical resistance was within specification.No other device problems were noted.The reported event of "loop break" was confirmed.During visual and media analysis it was noted that the loop was broken and blackened/burnt.This could be caused due to an excessive application of power during the process, which causes an overheating and the burn and break of the loop.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.Based on the analysis of the returned device and the information available, the code selected as the most probable cause is adverse event related to procedure due to the adverse event occurred during the procedure and the device had no influence on the event.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

Event Description

It was reported to boston scientific corporation that a captivator small hexagonal stiff snare was used to remove a target polyp in the colon during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, the snare loop was darkened and looked burnt after using cautery.The photo of the complaint device showed that the snare loop was broken.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.

• 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: 12909801
• MDR Text Key: 286004722
• Report Number: 3005099803-2021-06157
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729071068
• UDI-Public: 08714729071068
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1