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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference: 3005334138-2018-00190, 2030404-2018-00050, 3005334138-2018-00199, 3005334138-2018-00200.Following an ablation procedure, a spasm occurred.A pardee wave was noted on the ecg due to the spasm of the right coronary artery, after all devices were withdrawn from the heart.The spasm was diagnosed via angiography.The procedure was able to be completed and the patient was stable with no symptoms.There were no performance issues with any abbott device.
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 spasm remains unknown.

• 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: 7673002
• Report Number: 3005334138-2018-00201
• Device Sequence Number: 16486248
• Product Code: DRF
• UDI-Device Identifier: 05415067025975
• UDI-Public: 05415067025975
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 07/24/2018

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: 6388728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 07/24/2018
• 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: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER (X2); TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SE
• Outcome Attributed to Adverse Event: Other