MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VIEWFLEX¿ CATHETER INTERFACE MODULE VIEWMATE¿ ZS3; SYSTEM, SIGNAL ISOLATION

Model Number H701374

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

During the procedure, the cim did not recognize the transducers.The catheter was reseated, replaced twice, the unit was power cycled, and the cim was reseated which did not resolve the issue.A separate ultrasound was brought into complete case with no patient consequences.

Manufacturer Narrative

Additional information: b5, d9, g3, h2, h3.One viewmate¿ z catheter interface module was received for analysis.The viewmate cim made a rattling noise when rotated.When the cim was opened, both of the internal coils are loose from the circuit board mounting provisions.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.Based on the information provided to abbott and the investigation performed, the reported communication issue was isolated to both broken strain relief (plastic zip tie) on the choke coils.

Event Description

The delay is not a reportable event.As this occurred during a left atrial appendage closure procedure.

• Brand Name: VIEWFLEX¿ CATHETER INTERFACE MODULE VIEWMATE¿ ZS3
• Type of Device: 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16658423
• MDR Text Key: 312459248
• Report Number: 2184149-2023-00075
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

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: 8862870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2023
• 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