MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D402865

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problems Pulmonary Edema (2020); Tricuspid Regurgitation (2112); Heart Failure (2206); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

During the procedure, the catheter appeared to get caught in the tricuspid valve.After removal from the tricuspid valve, the catheter was damaged and no longer performing as expected.An electrode was also displaced on the catheter.The following morning, the patient was showing moderate to serve tricuspid regurgitation, heart failure and pulmonary edema.

Manufacturer Narrative

Additional information: d9, g3, h2, h3, h6 one decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.The reported displaced electrode and deflection issue was confirmed.The catheter no longer met specifications when deflected in either direction, due to the bend in the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bend and the displaced electrode is consistent with damage during use.

• Brand Name: REFLEXION SPIRAL VARIABLE RADIUS CATHETER 5 F LOOP BI-DIRECTIONAL, 7F
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 11031703
• MDR Text Key: 222288988
• Report Number: 2182269-2020-00115
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K072012
• 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: 02/16/2021

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
• Device Expiration Date: 03/31/2022
• Device Model Number: D402865
• Device Lot Number: 6957649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other