MAUDE Adverse Event Report: ST. JUDE MEDICAL AMPERE RF ABLATION GENERATOR; EP GENERATOR

Model Number H700489

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/08/2021

Event Type  malfunction  

Event Description

During a pulmonary veins isolation (pvi) procedure, the ampere displayed the error "catheter not connected".Additionally, noise was observed on the ablation catheter and high temperature (90 degrees).The catheter connector cable was exchanged three times, but the error persisted.The catheter was exchanged, but the issue persisted.The procedure was unable to be completed.There were no adverse patient consequences.

Manufacturer Narrative

Additional information : d9, g3, g6, h2, h3, h6 one ampere¿ rf ablation generator was received for evaluation.The returned generator was powered up and the unit completed the post successfully and the screen display came up normally.All connector ports were tested for functionality, numerous catheter codes were manually applied, various impedance & temperature values were also applied for investigation upon which all values were accurately tracked on the generator¿s display screen.Rf energy output was measured during ablation testing and no anomalies were identified throughout the investigation.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 reported event was unable to be confirmed.

• Brand Name: AMPERE RF ABLATION GENERATOR
• Type of Device: EP GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11759674
• MDR Text Key: 250830123
• Report Number: 2184149-2021-00109
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

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: H700489
• Device Lot Number: 7675047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1