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 Material Frayed (1262); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

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 an atrial fibrillation procedure, the catheter would not deflect as intended while mapping.The catheter was removed from the patient and upon visual inspection, the insulation of the catheter shaft had split.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

The reported shaft damage was confirmed.Visual inspection showed a fracture in the shaft at the spiral loop/shaft transition.Further investigation concluded that the fracture in the shaft was due to a weak bonding at the spiral loop/shaft transition.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9676032
• MDR Text Key: 179109151
• Report Number: 2182269-2020-00011
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734206204
• UDI-Public: 05414734206204
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2020

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: 08/31/2022
• Device Model Number: 402804
• Device Catalogue Number: 402804
• Device Lot Number: 7062202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 91