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

Model Number	H701374
Medical Device Problem Codes	Communication or Transmission Problem (2896); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation ablation procedure, the catheter interface module (cim) would not recognize the ice catheter and the procedure was cancelled as a result.The catheter was initially replaced, but the issue remained.A rattling sound was noted to be coming from within the cim.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One viewmate¿ z catheter interface module was received into the lab for analysis without original packaging available for inspection.Visual inspection found all labeling and input/output connectors to be free of physical damage.The viewmate cim made a rattling noise when rotated.When the cim was opened, one of the internal coils are loose from the circuit board mounting provisions.Based on the information provided to abbott and the investigation performed, the reported event of no communication was confirmed.The root cause was isolated to one broken strain relief (plastic zip tie) on the choke coils.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.

• Brand Name: VIEWMATE¿ Z CATHETER INTERFACE MODULE
• Common Device Name: SYSTEM, SIGNAL ISOLATION
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13192769
• Report Number: 2184149-2022-00002
• Device Sequence Number: 5983800
• Product Code: DRJ
• UDI-Device Identifier: 05415067013743
• UDI-Public: 05415067013743
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 5967765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• 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: 01/04/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2017
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White