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

Model Number	M00562321
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present on device.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used to remove polyp in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2023.During the procedure and inside the patient, while pushing the handle, rust was found in the metal position inside the handle and electrode position.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a180104 captures the reportable event of foreign material present on device.Block h10: investigation results: a captivator snare was received for analysis.Visual inspection of the returned device revealed no damages were found, however, there were residues inside the catheter and handle.In addition, per microscopic inspection, the 2 in 1 connector was rusty.No other problems were noted.The reported complaint of device foreign material present in device was confirmed since there was evidence of rust residues on the returned device.It is important to mention that boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.In conclusion, the manufacturing process has revisions at different stations from the components reported are assembled to the last step of manufacturing process, therefore, it is possible to confirm that bsc has enough controls to reduce the chances of selling devices with rust.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a captivator snare was used to remove polyp in the colon during an endoscopic mucosal resection (emr) procedure performed on (b)(6) 2023.During the procedure and inside the patient, while pushing the handle, rust was found in the metal position inside the handle and electrode position.The procedure was completed with another captivator snare.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.

• Brand Name: CAPTIVATOR
• Common Device Name: 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: 18456937
• Report Number: 3005099803-2023-06977
• Device Sequence Number: 7079405
• Product Code: FDI
• UDI-Device Identifier: 08714729019336
• UDI-Public: 08714729019336
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K202478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2025
• Device Model Number: M00562321
• Device Catalogue Number: 6232
• Device Lot Number: 0030113021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 90 KG