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

Model Number	401261
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Following an atrioventricular nodel reentry tachycardia procedure, the outer material of the catheter was damaged, exposing the internal wires after removing the catheter from the patient.No difficulty was noted inserting or withdrawing the catheter.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One response¿ electrophysiology catheter was returned for investigation.The reported shaft damage was confirmed.The shaft of the catheter was noted to be separated between the grey and black braided shaft portion due to an inefficient bonding technique.

• Brand Name: RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, EL
• Common Device Name: 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: 8191587
• Report Number: 3008452825-2018-00441
• Device Sequence Number: 11280131
• Product Code: DRF
• UDI-Device Identifier: 05414734200592
• UDI-Public: 05414734200592
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K894500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 401261
• Device Lot Number: 6308248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AVANTI 6F SHEATH