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

Model Number H700494

Device Problem High impedance (1291)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation procedure, impedance issues resulted in the procedure being cancelled.It was noted that there was high impedance (above 150 ohms) during ablation.The rf cables and catheter were exchanged, but the issue persisted and the procedure was cancelled.There are no reported adverse patient consequences.

Manufacturer Narrative

One ampere¿ rf ablation generator was received for evaluation.The product functioned as anticipated during testing with no abnormalities identified that would result in the reported complaint.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, root cause of the field reported event could not be conclusively determined as the returned ampere generator functioned as anticipated, with no anomalies identified that would result in the reported complaint.

• Brand Name: AMPERE¿ GENERATOR KIT
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16900083
• MDR Text Key: 314891256
• Report Number: 2184149-2023-00100
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 05415067004949
• UDI-Public: 05415067004949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700494
• Device Catalogue Number: H700494
• Device Lot Number: 4847378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male