MAUDE Adverse Event Report: ST. JUDE MEDICAL SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401430
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/09/2019
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 vein dissection was procedure related.Per the ifu, dissection is a known procedural risk during the use of this device.
Event or Problem Description
During an icd implant procedure, a subclavian vein dissection occurred.Angiography confirmed a clear path to the superior vena cava (svc).After inserting the guidewire and introducer, the lead and catheter were advanced under fluoroscopic guidance.Resistance was noted between the svc and subclavian vein.The lead was advanced to the tip of the catheter and the catheter was pushed forward and passed the resistance.At that moment, the patient complained of chest pain.Contrast fluid was injected and was observed spreading through the mediastinum confirming a dissected area where the vein made a 90 degree angle.The patient was transferred for vascular surgery and is in stable condition.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 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: 8792743
• Report Number: 3008452825-2019-00336
• Device Sequence Number: 11257224
• Product Code: DRF
• UDI-Device Identifier: 05414734201285
• UDI-Public: 05414734201285
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K894500
• 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): 07/16/2019

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: 02/28/2022
• Device Model Number: 401430
• Device Lot Number: 6910935
• 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: 07/09/2019
• Initial Report FDA Received Date: 07/16/2019
• 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