MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOCATION REFERENCE PATCH KIT; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	2352
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure to treat an atrial fibrillation (afib), a location reference patch kit was selected for use.One of the patches was dirty, and there seemed to be foreign object.Procedure was able to be completed successfully using another patch from the same package.No patient complications were reported.The device has been returned for analysis.
Additional Manufacturer Narrative
The backpatch was evaluated by boston scientific.Upon receipt at our post market quality assurance laboratory, the returned backpatch was visually damaged.Laboratory analysis determined that there was a microscopic piece of metal cause corrosion.Investigation was able to confirm the reported clinical observation of contamination.
Event or Problem Description
It was reported that during an ablation procedure to treat an atrial fibrillation (afib), a location reference patch kit was selected for use.One of the patches was dirty, and there seemed to be foreign object.Procedure was able to be completed successfully using another patch from the same package.No patient complications were reported.The device has been returned for analysis.

• Brand Name: LOCATION REFERENCE PATCH KIT
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): LEAD-LOK INCORPORATED; 804 airport way; sandpoint ID 83864
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19754985
• Report Number: 2124215-2024-43973
• Device Sequence Number: 12395143
• Product Code: DQK
• UDI-Device Identifier: 00191506000813
• UDI-Public: 00191506000813
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/30/2024

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: 02/19/2026
• Device Model Number: 2352
• Device Catalogue Number: 2352
• Device Lot Number: 0020025969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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 Sex: Unknown