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

Model Number H701374

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/30/2021

Event Type  malfunction  

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.Functional testing revealed the ultrasound console did not detect the catheter, which confirmed the field reported issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided to abbott and the investigation performed, the root cause of the field reported issue was isolated abnormal functionality the catheter detection circuitry.

Event Description

During a cryo atrial fibrillation ablation procedure, the cim did not recognize the catheters.A transesophageal echocardiogram (tee) was performed instead with anesthesia administered to complete the procedure successfully with no consequences to the patient.

• Brand Name: VIEWMATE Z CATHETER INTERFACE MODULE
• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11715358
• MDR Text Key: 250180446
• Report Number: 2184149-2021-00116
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2021

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: 6041752
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/23/2021
• Date Device Manufactured: 07/07/2017
• 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