MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿; ELECTRODE RECORDING CATHETER

Model Number	D-AVSE-DF10-F15
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported withdrawal difficulty may have been procedure related.
Event or Problem Description
During a pulmonary vein isolation procedure, the device became entangled near the patient's mitral valve.The catheter was advanced via antegrade approach and mapping began in the left atrium.While mapping, the catheter became entangled in the patient's mitral valve.Open chest surgery was required in order to avoid damaging the mitral valve or chordae tendineae during percutaneous removal of the catheter.The catheter tip was cut and the remainder of the catheter was removed from the sheath while the catheter tip was successfully extracted and there was no damage to the mitral valve.The procedure was successfully completed with a replacement catheter and the patient is in stable condition.The physician felt the cause was procedure related and not due to a performance issue with any abbott device.

• Brand Name: ADVISOR¿ FL, CIRCULAR MAPPING CATHETER, SENSOR ENABLED¿
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7931374
• Report Number: 3005334138-2018-00348
• Device Sequence Number: 2064225
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: 05415067025975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/03/2018

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 Expiration Date: 09/30/2019
• Device Model Number: D-AVSE-DF10-F15
• Device Lot Number: 6421831
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention