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

Model Number H700489

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a pulmonary vein (pv) isolation procedure a clinically significant delay occurred.While ablating, no power was delivered from the generator to the ablation catheter.The ablation catheter was exchanged with no improvement.Approximately one hour into ablation without any success in isolating the pv the ampere generator was exchanged.The procedure was completed with no further delay and no patient consequences.

Manufacturer Narrative

This model number is not commercially available in the u.S.; however, it is similar to a device sold in the u.S.The product code and pma number, is the information for the similar comparator device.

Manufacturer Narrative

Additional information: one ampere¿ rf ablation generator was received for analysis.All connector ports were tested for functionality, numerous catheter codes were manually applied, various impedance and temperature values were also applied for investigation upon which all values were accurately tracked on the generator¿s display screen.Radiofrequency (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.When a known good irrigation pump was connected to the generator, communication was successfully established confirmed by the pump icon having illuminated on the generator¿s display screen.When ablation function was tested with a known good irrigated catheter, the pump automatically went into high flow (approximately 5ml/min) as anticipated.Review of system log files proved to be inconclusive as no hardware faults were documented on the reported event date.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, root cause of the reported abnormal radiofrequency output and subsequent delayed procedure could not be conclusively determined as the returned ampere¿ generator performed as anticipated with no anomalies identified.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Type of Device: EP GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8633439
• MDR Text Key: 145842294
• Report Number: 2184149-2019-00095
• Device Sequence Number: 1
• Product Code: OAD
• 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,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700489
• Device Lot Number: 6446822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other