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 07/03/2019

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.At the start of the procedure there was noise noted on the distal electrodes of the reflexion spiral catheter.The pair were deselected and the procedure was continued.At the end of the case there was resistance when withdrawing the catheter back into the introducer.The curve of the catheter was readjusted but there was no resolution.The introducer and catheter were withdrawn as one unit from the right femoral vein.The catheter was visually inspected and a break in the outside case was noted along with exposure of the push-pull cables at the proximal end of the spiral/shaft connection.Contract injection was used to check for any injury to the patient during catheter/introducer withdrawal with no trauma observed.

Manufacturer Narrative

One duo-decapolar, bi-directional, variable radius, reflexion spiral catheter was received for evaluation.The catheter shaft was torn and separated at the spiral loop/shaft transition exposing the internal wires.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event 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: 8823052
• MDR Text Key: 152086343
• Report Number: 2182269-2019-00097
• 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: 10/17/2019

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 Expiration Date: 02/28/2022
• Device Model Number: 402804
• Device Catalogue Number: 402804
• Device Lot Number: 6899346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 101