MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ELECTROPHYSIOLOGY (STEERABLE); CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problems Difficult to Insert (1316); No Apparent Adverse Event (3189)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  Injury  

Event Description

During the procedure, insertion difficulties were noted when attempting to advance the ep catheter to cannulate the coronary sinus (cs).The catheter was removed, and a contract venogram was performed demonstrating a dissection of the main cs into the epicardial fat.An attempt to cannulate the true lumen was unsuccessful.More proximally, engaged what appeared to be the middle cardiac vein and a contract venogram showed evidence of dissection.One more attempt to cannulate the true lumen was attempted, but unsuccessful.The procedure was terminated and the lv port was capped.No other treatment was required.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported dissection could not be conclusively determined.

Event Description

An abbott supreme ep catheter was used, however it was resterilized by stryker and is therefore no longer considered an abbott product.

• Brand Name: ELECTROPHYSIOLOGY (STEERABLE)
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18405922
• MDR Text Key: 331477314
• Report Number: 2182269-2023-00058
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 87 KG