MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA INQUIRY¿ ELECTROPHYSIOLOGY CATHETERS, DECAPOLAR, 6F; CATHETER, ELECTRODE RECORDING

Model Number	IBI-81102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/13/2018
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 tamponade could not be conclusively determined.Per the ifu, vascular perforation is an inherent risk of any electrode placement.
Event or Problem Description
Related manufacturing ref: 9680001-2018-00112, 3008452825-2018-00260, 2030404-2018-00054.During a pulmonary vein isolation procedure, a cardiac perforation occurred in the left atrium.During the procedure, geometry of the left atrium was created and the left pulmonary veins were successfully isolated.While isolating the right pulmonary veins, the introducer sheath shifted to the right atrium, together with the ablation catheter.While repositioning the introducer sheath, the patient¿s vitals went down.An echocardiogram was performed which revealed a tamponade.A drain was successfully placed, but vitals remained low.Cardiopulmonary resuscitation was performed although the patient still had rhythm.The patient was transferred to surgery for repair and is in stable condition.There were no performance issues with any abbott devices.

• Brand Name: INQUIRY¿ ELECTROPHYSIOLOGY CATHETERS, DECAPOLAR, 6F
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 7761993
• Report Number: 3008452825-2018-00261
• Device Sequence Number: 11188919
• Product Code: DRF
• UDI-Device Identifier: 05414734302968
• UDI-Public: 05414734302968
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K961924
• 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): 08/08/2018

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: 03/31/2021
• Device Model Number: IBI-81102
• Device Catalogue Number: IBI-81102
• Device Lot Number: 6428926
• 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: 07/13/2018
• Initial Report FDA Received Date: 08/08/2018
• 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; INQUIRY OPTIMA CATHETER; TACTICATH ABLATION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention