MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AMPERE¿ REMOTE CONTROL; GENERATOR, LESION, RADIOFREQUENCY

Model Number	H700490
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturing reference: 2182269-2018-00107, 9680001-2018-00127, 2184149-2018-00145.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.
Additional Manufacturer Narrative
One assembly rf gen ii remote was received for evaluation.All controls worked as intended when ac power was applied to the ampere remote.Inputted various impedance levels using a decade box with no abnormal results.Verified temperature readings.Simulated an ablation with no problems.Based on the information provided to abbott and the investigation performed, the reported impedance issue was unable to be confirmed.The returned product functioned properly during the evaluation.No hardware abnormalities that would have resulted in the reported event were 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.

• Brand Name: AMPERE¿ REMOTE CONTROL
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 7833355
• Report Number: 2184149-2018-00144
• Device Sequence Number: 1835394
• Product Code: GXD
• UDI-Device Identifier: 05415067004901
• UDI-Public: 05415067004901
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H700490
• Device Lot Number: 4558993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS¿ NXT STEERABLE INTRODUCER; AMPERE¿ RF ABLATION GENERATOR; TACTICATH¿ QUARTZ; AGILIS¿ NXT STEERABLE INTRODUCER; AMPERE¿ RF ABLATION GENERATOR; TACTICATH¿ QUARTZ
• Outcome Attributed to Adverse Event: Other