MAUDE Adverse Event Report: ST. JUDE MEDICAL AMPERE RF ABLATION GENERATOR; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number H700488

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/11/2021

Event Type  malfunction  

Event Description

During an av-nodal reentrant tachycardia (avnrt) procedure without mapping, there was no signal on the ablation-catheter-channel displayed at ge-cardiolab system.Troubleshooting with the customer was without success and the procedure was cancelled.The ampere was replaced and the issue was resolved.There were no adverse patient consequences.

Manufacturer Narrative

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 investigation as rf output was correctly displayed and measured over an extensive test period.Review of system log files provided inconclusive data as no anomalies were found for the reported event date.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the cause of the reported event remains unknown.

• Brand Name: AMPERE RF ABLATION GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11632078
• MDR Text Key: 244384846
• Report Number: 2184149-2021-00082
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• Combination Product (y/n): N
• PMA/PMN Number: P110016
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700488
• Device Catalogue Number: H700488
• Device Lot Number: 5566549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1