MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. REFLEXION SPIRAL¿ VARIABLE RADIUS CATHETER 6 F LOOP BI-DIRECTIONAL, 7F; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 402804

Device Problems Difficult to Remove (1528); Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a pulmonary vein isolation procedure the catheter became stuck in the patient.While maneuvering the catheter in the right inferior pulmonary vein in the left atrium, a snap within the catheter handle was felt.Fluoroscopy was used to try to guide the catheter back into the introducer but it was not possible since the control wire was exposed.The catheter and introducer were removed as one unit to the insertion site.The handle of the catheter was cut in order to utilize short sheaths to safely retrieve the catheter.Once removed, contrast injection was used to check for any injury to the patient during catheter/introducer withdrawal with no trauma observed.

Manufacturer Narrative

Additional information: g4, g7, h2, h3, h6; one duo-decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.Upon visual inspection the spiral loop was noted to be fractured and detached at the spiral loop/shaft transition and the shaft was cut off at the distal strain relief.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the damage to the catheter shaft and spiral loop is consistent with damage during use.

• Brand Name: REFLEXION SPIRAL¿ VARIABLE RADIUS CATHETER 6 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: 9124640
• MDR Text Key: 179107074
• Report Number: 2182269-2019-00169
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734206204
• UDI-Public: 05414734206204
• Combination Product (y/n): N
• PMA/PMN Number: K062251
• 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: 01/07/2020

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 Expiration Date: 03/31/2022
• Device Model Number: 402804
• Device Catalogue Number: 402804
• Device Lot Number: 6957661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 95