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

Model Number	401442
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Manufacturing related ref: 3005334138-2019-00502.During the procedure, when attempting to remove the hd grid catheter, it became entangled in another mapping catheter that was within the right atrium.The hd grid catheter was able to be removed but the distal portion of the other mapping catheter became detached.All portions of the catheter were able to be removed from the patient with the hd grid catheter.The hd grid catheter was then able to be used to continue and complete the procedure.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, ELE
• 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: 8995930
• Report Number: 3008452825-2019-00460
• Device Sequence Number: 3132779
• Product Code: DRF
• UDI-Device Identifier: 05414734201360
• UDI-Public: 05414734201360
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K894500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 401442
• Device Lot Number: 7000379
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention