MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, DECAPOLAR, 65 CM LENGTH, CSL¿ CURVE, ELECT; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	401353
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 6f, decapolar, csl, response ep catheter was received for evaluation.The catheter was returned due to damage.Visual inspection of the catheter showed a fracture in the shaft.Further investigation revealed the shaft fracture to be due to improper bonding between the grey and black shaft portions.
Event or Problem Description
This report is to advise of an event observed during analysis confirming a fractured catheter shaft with exposed internal wiring.

• Brand Name: RESPONSE¿ ELECTROPHYSIOLOGY CATHETER, DECAPOLAR, 65 CM LENGTH, CSL¿ CURVE, ELECT
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 9540672
• Report Number: 3008452825-2020-00002
• Device Sequence Number: 2407791
• Product Code: DRF
• UDI-Device Identifier: 05414734200899
• UDI-Public: 05414734200899
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 01/02/2020

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
• Operator of Device: No Information
• Device Expiration Date: 05/31/2021
• Device Model Number: 401353
• Device Lot Number: 6509907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1