MAUDE Adverse Event Report: MEDLINE RENEWAL CARTO¿ 3 SYSTEM INTERFACE CABLE,34 PIN-BLUE TO 12 PIN-BLUE; BW EP CATH CARTO CABLE FOR DX CATH B

Catalog Number	CB3412CTR
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported it was reported that "digital signals 1-2 do not work." there were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
It was reported that "digital signals 1-2 do not work.".

• Brand Name: CARTO¿ 3 SYSTEM INTERFACE CABLE,34 PIN-BLUE TO 12 PIN-BLUE
• Common Device Name: BW EP CATH CARTO CABLE FOR DX CATH B
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond avenue 94456 1876
• Manufacturer Contact: leann gifford ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 25492177
• Report Number: 3032391-2026-00033
• Device Sequence Number: 21411296
• Product Code: IKD
• UDI-Device Identifier: 20193489189725
• UDI-Public: 20193489189725
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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 Catalogue Number: CB3412CTR
• Device Lot Number: CC260401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Unknown