MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ CANNULATOR¿ 7F 80CM LG CRL STEERABLE EP CATHETER; ELECTRODE RECORDING CATHETER

Model Number	401786
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/25/2019
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 dissection remains unknown.
Event or Problem Description
During a lv lead implant procedure, dissection of the coronary sinus occurred during cannulation with the catheter.No intervention was required and the patient is in stable condition.The icd was successfully implanted with ra and rv leads.The lv lead positioning will be attempted again in approximately 4 weeks.

• Brand Name: LIVEWIRE¿ CANNULATOR¿ 7F 80CM LG CRL STEERABLE EP CATHETER
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8585829
• Report Number: 2182269-2019-00055
• Device Sequence Number: 2294038
• Product Code: DRF
• UDI-Device Identifier: 05414734202510
• UDI-Public: 05414734202510
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102721
• 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): 05/07/2019

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: 03/31/2021
• Device Model Number: 401786
• Device Lot Number: 6412617
• 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: 04/25/2019
• Initial Report FDA Received Date: 05/07/2019
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 92