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

Model Number H700488

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2018

Event Type  Injury  

Event Description

Related manufacturing reference: 2182269-2018-00107, 9680001-2018-00127, 2184149-2018-00144 during an atrial fibrillation ablation procedure a cancellation occurred.While ablating in the left atrium, approximately 1 hour into the procedure, an impedance of 999 was displayed on the remote control and the generator.Additionally a "pop" was felt by the user from either the catheter or the sheath within the patient.The sheath and the catheter were examined for abnormalities.The sheath was noted to be difficult to maneuver but no visible abnormalities were observed.The impedance from the generator however did not improve and the case was cancelled.The patient was stable.

Manufacturer Narrative

One ampere¿ rf ablation generator was received for analysis.Based on the information provided to abbott and the investigation performed, root cause of the field reported event citing an increase in impedance could not be conclusively determined.The returned rf generator functioned as intended throughout testing and any hardware fault documented in the engineering log files could not be successfully reproduced during investigation.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.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7833378
• MDR Text Key: 118782527
• Report Number: 2184149-2018-00145
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 05415067004888
• UDI-Public: 05415067004888
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• 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: 4609103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• 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
• Treatment: AGILIS¿ NXT STEERABLE INTRODUCER; AMPERE¿ REMOTE CONTROL; TACTICATH¿ QUARTZ
• Patient Outcome(s): Other