MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. LIVEWIRE¿ DIAGNOSTIC CATHETER MEDIGUIDE ENABLED¿, MEDIUM SWEEP ELECTRODE SPACING; CATHETER, ELECTRODE RECORDING

Model Number D402058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemothorax (1896); Vascular Dissection (3160)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported hemothorax was procedure related.

Event Description

During a crt revision procedure, a hemothorax occurred.An angiogram during the procedure revealed a dissection of the brachiocephalic vein.The patient remained stable and the procedure was successfully completed.Following the procedure, a ct scan confirmed the hemothorax but no aspiration was performed.However, the patient received two blood transfusions.There were no performance issues with any sjm device.

Event Description

Additional information indicated a chest tube was placed to treat the hemothorax and the patient remained hospitalized for several days.

• Brand Name: LIVEWIRE¿ DIAGNOSTIC CATHETER MEDIGUIDE ENABLED¿, MEDIUM SWEEP ELECTRODE SPACING
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5948823
• MDR Text Key: 54642169
• Report Number: 3005188751-2016-00061
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K101955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: D402058
• Device Lot Number: 5411223
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PRESSURE PRODUCTS SAFESHEATH II INTRODUCER; UNKNOWN CPS MEDIGUIDE SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 60