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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿ ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE Back to Search Results
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.

 
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Brand NameADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
Type of DeviceELECTRODE 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 Key7684829
MDR Text Key113868221
Report Number3005334138-2018-00206
Device Sequence Number1
Product Code MTD
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK172393
Number of Events Reported1
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 Received07/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2019
Device MODEL NumberD-AVHD-DF16
Device LOT Number6488690
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 Received07/24/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/27/2018
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
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