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

Model Number H701374

Device Problems Communication or Transmission Problem (2896); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 284208674
• Report Number: 2184149-2022-00002
• Device Sequence Number: 1
• Product Code: DRJ
• UDI-Device Identifier: 05415067013743
• UDI-Public: 05415067013743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White