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

Model Number M00561311

Device Problem Failure to Deliver Energy (1211)

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

Event Date 02/25/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on (b)(6) 2023.During the procedure, in an attempt to use esu with the snare, the esu did not work.They used a hot biopsy forceps and it worked.It was not reported what device was used to complete the procedure.It was not reported if there were no patient complications reported as a result of this event.

Manufacturer Narrative

Imdrf device code (b)(4) captures the reportable event of device could not deliver energy.

Manufacturer Narrative

Block h6: imdrf device code a090402 captures the reportable event of device could not deliver energy.Block h10: (product investigation) one captivator snare was received for analysis.There were no issues noted during visual analysis.The 2 in 1 connector was dimensionally inspected and was found to be within specification.Electrical testing was performed, and the device's electrical resistance was within specification.No other device problems were noted.The reported event of "device failed to deliver energy" could not be confirmed.Electrical testing was performed during product analysis and the device's electrical resistance was found to be within specification.Based on the analysis of the returned device and the information available, the code selected as the most probable root cause is no problem detected since the reported event could not be confirmed.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on (b)(6) 2023.During the procedure, in an attempt to use esu with the snare, the esu did not work.They used a hot biopsy forceps and it worked.It was not reported what device was used to complete the procedure.It was not reported if there were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a captivator large oval med stiff snare was used during a procedure performed on (b)(6) 2023.During the procedure, in an attempt to use esu with the snare, the esu did not work.They used a hot biopsy forceps and it worked.It was not reported what device was used to complete the procedure.It was not reported if there were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a090402 captures the reportable event of device could not deliver energy.

• 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: 16582021
• MDR Text Key: 311784985
• Report Number: 3005099803-2023-01433
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 08714729019251
• UDI-Public: 08714729019251
• 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,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00561311
• Device Catalogue Number: 6131
• Device Lot Number: 0030623220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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