MAUDE Adverse Event Report: STERILMED, INC. DUO-DECAPOLAR CATHETER SUPER LARGE CURL; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	DAI401905
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Middle-aged male with history of htn (hypertension), morbid obesity and atrial fibrillation.Procedure: ablation with carto.The duo-decapolar catheter would not steer.Unable to be used so it was removed without difficulty.A new device was used without further issues.No known harm to patient, minor delay in procedure.Manufacturer response for catheter, recording, electrode, reprocessed, na (per site reporter).Will obtain.

• Brand Name: DUO-DECAPOLAR CATHETER SUPER LARGE CURL
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n; suite 2; plymouth MN 55446
• MDR Report Key: 17555482
• Report Number: 17555482
• Device Sequence Number: 3584005
• Product Code: NLH
• UDI-Device Identifier: 10888551008839
• UDI-Public: (01)10888551008839(17)240327(10)2193369
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/08/2023
• Report Date (Section F): 08/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: DAI401905
• Device Catalogue Number: DAI401905
• Device Lot Number: 2193369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 170 KG
• Date Report Sent to FDA: 08/08/2023