MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 1500T11 -CP CARDIAC ABLATION GENERATOR; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 85523

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

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.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported impedance issue and subsequent procedure cancellation could not be conclusively determined.

Event Description

During the procedure, the generator displayed a "hi" message and ablation was unable to be performed.Troubleshooting included changing the rf patches, flexibility cable, and catheter with no resolution.The procedure was rescheduled for a later date.There were no adverse patient consequences due to the cancellation.

Manufacturer Narrative

Additional information: g4, g7, h2, h4, h10.

Manufacturer Narrative

One 1500t11 -cp cardiac ablation generator was returned for investigation.Ac power was applied to the returned rf generator which briefly displayed the software version of 3.0 prior to completing a successful power on self-test.Default values were then displayed in numerical format that is consistent with this software version.Functional testing revealed a displayed impedance value of ¿hi¿ due to an open electrical circuit at the indifferent electrode 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 error message and subsequent procedure cancellation was isolated to an open electrical circuit at the indifferent electrode connector.

• Brand Name: 1500T11 -CP CARDIAC ABLATION GENERATOR
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• MDR Report Key: 10283151
• MDR Text Key: 199085247
• Report Number: 2030404-2020-00047
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P060019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 72