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

Model Number D-AVHD-DF16

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

Event Type  malfunction  

Event Description

Following a ventricular tachycardia ablation procedure a catheter detachment occurred.The catheter was removed from the patient and inspected, the plastic casing along the catheter splines appeared damaged or missing.The catheter was advanced into the patient via transseptal approach with an 8.5f large curl agilis sheath and through an 8f short sheath for retrograde aortic access into the left ventricle (lv).During the procedure the catheter had gone from the transseptal to retrograde access back to transseptal and was utilized to stabilize the flexibility catheter during ablation of the basal anterior lv.There were no adverse patient consequences.

Manufacturer Narrative

One advisor hd grid mapping catheter was received for evaluation.The distal coupler was shifted causing the spline material to be compressed in the direction of the shift.Additionally, the outer spline was torn, exposing the nitinol frame.The advisor hd instructions for use states "insert the distal tip section of catheter into an 8.5 f minimum introducer using the insertion tool." the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported damage is consistent with damage during use.

• Brand Name: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8219318
• MDR Text Key: 132222719
• Report Number: 3005334138-2019-00005
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K172393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-AVHD-DF16
• Device Lot Number: 6435736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1