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

Model Number H700489

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2019

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 supraventricular tachycardia ablation procedure a cancellation occurred due to an impedance issue.While ablation was off impedance increased to the limit of 300 ohms and decreased to the normal value.To resolve the issue the power cord, radiofrequency patch, ablation cables and catheter were all exchanged along with power cycling the system but the impedance jump still occurred.The case was cancelled.There were no adverse patient consequences.

Manufacturer Narrative

One ampere¿ rf ablation generator was received for inspection.When power was applied to the generator, a normal boot up sequence was observed and all touch pad controls functioned normally with no error messages displayed.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.The generator was then tested in conjunction with a known good velocity system and rf energy output was measured during ablation testing.No anomalies were identified throughout investigation as rf output was correctly displayed and measured over an extensive test period with any noise or abnormal impedance values identified.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 field reported event citing abnormal impedance values could not be conclusively determined as the returned ampere generator functioned as anticipated throughout investigation.

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 listed in section d1 is the information for the similar comparator device.

• 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: 9174495
• MDR Text Key: 161799739
• Report Number: 2184149-2019-00182
• 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: 10/10/2019
• 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: 6385347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• 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