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 Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During a procedure, the catheter interface module (cim) would no longer recognize the probes.The patient was already prepared when the procedure was cancelled.There were no adverse consequences to the patient.
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.The ultrasound console failed to detect the catheter, which confirms the field reported issue.Inspect of the internal components revealed an open electrical circuit within the catheter detection circuitry due to a partially dislodged electrical connector.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated to an open electrical circuit within the catheter detection circuitry.

• 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: 10060771
• Report Number: 2184149-2020-00065
• Device Sequence Number: 3572545
• Product Code: DRJ
• UDI-Device Identifier: 05415067013743
• UDI-Public: 05415067013743
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K151175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H701374
• Device Catalogue Number: H701374
• Device Lot Number: 5144886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other