MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number D-AVHD-DF16

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  Injury  

Event Description

Related manufacturing ref: 3008452825-2018-00236. During the procedure, the mapping and fixed curve catheters became entangled around an inferior vena cava filter (ivc) filter from the groin. The ivc filter was snared with a device from a superior ij access site. Once the ivc filter was secured with the snare device, the entangled catheters were freed from the ivc filter. The filter was then completely extracted using the snare and a sheath from the superior access. The handle of the fixed catheter was cut off as it was still entangled in the mapping catheter and both devices were removed via an introducer.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis; however, one image was provided for evaluation. Based solely on the aforementioned image, the catheter appeared to be caught with another catheter at the distal end of the paddle. In addition, one spline was fractured at the distal end of the paddle. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The cause of the reported entanglement remains unknown. The advisor hd grid mapping catheter, sensor enabled ifu state: careful catheter manipulation must be performed in order to avoid device component damage. The ifu also states: catheter entrapment within the heart or blood vessels is a possible complication of electrophysiology procedures. Always straighten the catheter before insertion or withdrawal.

• Brand Name: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: elizabeth boltz ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7684829
• MDR Text Key: 113868221
• Report Number: 3005334138-2018-00206
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/13/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 09/30/2019
• Device MODEL Number: D-AVHD-DF16
• Device LOT Number: 6488690
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/27/2018
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 07/13/2018 Patient Sequence Number: 1