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 Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/14/2021

Event Type  Injury  

Event Description

Manufacturer report numbers: 3008452825-2021-00346.During an supraventricular tachycardia (svt) procedure, when the advisor hd grid was attempted to be pulled back from the right atrium through a short 9f sheath, the catheter would not collapse enough to be pulled back through the sheath.The catheter was re-advanced into the right atrium and an x-ray showed the splines of the grid (a and b) had been tangled around each other.After several attempts of pulling the grid back through the sheath with clockwise and counterclockwise motions, the sheath and catheter were pulled back at the same time out of the femoral vein.The tangled tip of the catheter then became stuck at the access point in the groin.The shaft of the grid was cut so the sheath could be back loaded over it.Once the sheath was as far over the tangled catheter, both the sheath and the grid were pulled out and the access site was sutured.A new access site was created on the same side and replacement advisor hd grid was advanced into the heart.After manipulating the hd grid in the la for less than 3 minutes, the patient became hypotensive and an effusion was noted on ice near the la appendage.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott devices.

Manufacturer Narrative

Additional information: g3, g6.H2, h3, h6.One bi-directional, curve d-f, sensor enabled, advisor hd grid mapping catheter was received for evaluation.The electrodes were displaced and the pellethane tubing and splines were corrugated and torn.The paddle was returned cut from the catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported effusion remains unknown.The cause of the torn pellethane tubing, cut shaft and displaced electrodes 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; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 12146269
• MDR Text Key: 260962918
• Report Number: 3008452825-2021-00345
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05415067028198
• UDI-Public: 05415067028198
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: D-AVHD-DF16
• Device Catalogue Number: D-AVHD-DF16
• Device Lot Number: 7915765
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 104