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

Model Number H701374

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

The results, method and conclusion codes along with the investigation results will be provided in a subsequent submission.

Event Description

During a procedure, the image was poor when the ice catheter was in use.Different catheters were used but the issue remained.As no replacement catheter interface module (cim) was available, the procedure was cancelled.There were no adverse consequences to the patient.

Manufacturer Narrative

Additional information: the results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be determined.

• 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
• MDR Report Key: 8683609
• MDR Text Key: 147498475
• Report Number: 2184149-2019-00107
• Device Sequence Number: 1
• Product Code: DRJ
• UDI-Device Identifier: 05415067013743
• UDI-Public: 05415067013743
• Combination Product (y/n): N
• PMA/PMN Number: K120703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H701374
• Device Catalogue Number: H701374
• Device Lot Number: 4947892
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 93