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

Model Number	401353
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	04/21/2020
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 cardiac perforation could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during use of this device.
Event or Problem Description
During a left ventricular crt-d implant procedure, a possible cardiac perforation occurred.It was not possible to cannulate the coronary sinus due to the patient's anatomy.A possible perforation was observed using contrast near the orifice of the coronary sinus and the procedure was stopped.The patient was implanted with a right atrial and right ventricular lead and a left ventricular lead will be implanted at a later date.The patient is in stable condition.There were no performance issues with any abbott device.

• 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; 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: 10055647
• Report Number: 3008452825-2020-00229
• Device Sequence Number: 11458989
• Product Code: DRF
• UDI-Device Identifier: 05414734200899
• UDI-Public: 05414734200899
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/14/2020

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: 09/30/2022
• Device Model Number: 401353
• Device Catalogue Number: 401353
• Device Lot Number: 7247665
• 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: 04/21/2020
• Initial Report FDA Received Date: 05/14/2020
• 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: Other