MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VIEWFLEX¿ CATHETER INTERFACE MODULE VIEWMATE¿ ZS3; 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	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One viewflex¿ catheter interface module viewmate¿ zs3 (cim) was received for evaluation.The cim was unable to be connected.Inspection of the internal components revealed two of the internal circuit boards were not fully seated into the connectors.Based on the information and investigation provided to abbott, the root cause was isolated to the connection of the internal circuit boards.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.
Event or Problem Description
During a pulmonary vein isolation (pvi) procedure, communication issues resulted in a procedural delay.It was reported that the cim for the viewmate multi did not display the ice probe.A different cim was borrowed from another site to complete the procedure which resulted in a 2 hour delay.The procedure was completed with no adverse consequences for the patient.

• Brand Name: VIEWFLEX¿ CATHETER INTERFACE MODULE VIEWMATE¿ ZS3
• Common Device Name: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19638666
• Report Number: 2184149-2024-00113
• Device Sequence Number: 7400333
• Product Code: DRJ
• UDI-Device Identifier: 05415067013743
• UDI-Public: (01)05415067013743(10)10097055
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2024

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 Model Number: H701374
• Device Catalogue Number: H701374
• Device Lot Number: 10097055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown