MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VIEWMATE Z CATHETER INTERFACE MODULE; SYSTEM, SIGNAL ISOLATION

Model Number	H701374
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One viewmate¿ z catheter interface module was received for analysis.Visual inspection of the returned module indicated signs of normal wear consistent with clinical use.No physical damage was detected to either connector end or module electrical terminals.Functional testing revealed the ultrasound console did not detect the catheter, which confirmed the field reported issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated abnormal functionality the catheter detection circuitry.
Event or Problem Description
During a cryo atrial fibrillation ablation procedure, the cim did not recognize the catheters.A transesophageal echocardiogram (tee) was performed instead with anesthesia administered to complete the procedure successfully with no consequences to the patient.

• Brand Name: VIEWMATE Z CATHETER INTERFACE MODULE
• Common Device Name: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11715358
• Report Number: 2184149-2021-00116
• Device Sequence Number: 14459625
• Product Code: DRJ
• UDI-Device Identifier: 05415067013743
• UDI-Public: 05415067013743
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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: H701374
• Device Catalogue Number: H701374
• Device Lot Number: 6041752
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1