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

Model Number H700488

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Following the end of a cryoablation procedure, ablation with radiofrequency was attempted in the cavotricuspid isthmus.The equipment was connected according to indication, however when the generator was switched on, an error message displayed ¿generator malfunction.Contact sjm technical support ¿.The equipment was turned off and reconnected, but the issue remained.The ablation was not continued and there were no patient consequences.

Manufacturer Narrative

One ampere¿ rf ablation generator was received for investigation.When power was applied to the generator, the screen illuminated red while displaying a generator malfunction error, confirming the reported event.The rf/mn (radiofrequency/matching network) assembly was temporarily replaced with a known good assembly and upon power cycle to the generator, a normal boot up sequence was observed.All connector ports were then 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, no abnormal impedance values were observed.The rf energy output was measured during ablation testing and no further anomalies were identified throughout investigation.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event was successfully isolated to abnormal functionality of the rf/mn assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.

• Brand Name: AMPERE¿ RF ABLATION GENERATOR
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9774877
• MDR Text Key: 189453315
• Report Number: 2184149-2020-00020
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700488
• Device Catalogue Number: H700488
• Device Lot Number: 6955465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other