MAUDE Adverse Event Report: ST. JUDE MEDICAL SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 401436

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

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 the supraventricular tachycardia ablation procedure, the catheter tip was broken.The catheter was replaced and the procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One 6f, quadripolar, jsn, supreme ep catheter was received for evaluation.The reported damage was confirmed.Further investigation found that the separation in the shaft was due to insufficient bonding between the grey and black portions of the braided shaft.Actions have been taken to prevent reoccurrence.

• Brand Name: SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE
• 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: 11163068
• MDR Text Key: 226572989
• Report Number: 3008452825-2021-00013
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 05414734201322
• UDI-Public: 05414734201322
• Combination Product (y/n): N
• PMA/PMN Number: K002976
• 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: 04/08/2021

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: 02/28/2023
• Device Model Number: 401436
• Device Catalogue Number: 401436
• Device Lot Number: 7427761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/09/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 04/02/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1