MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE; DIAGNOSTIC EP CATHETER

Model Number	401443
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During insertion of the catheter from the left ventricle, the catheter did not advance into the right atrium as intended.The catheter had formed a knot towards the distal end which could not be undone.A snare was advanced over the knot and the catheter was pulled back through the snare, untying itself in the process.The snare and catheter were safely retrieved.The procedure was completed with no consequences to the patient.
Additional Manufacturer Narrative
One 5f quadripolar supreme ep catheter was received for evaluation.Visual inspection revealed kinks and bends along the length of the shaft, consistent with the reported ¿knot¿ that formed during insertion of the catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the kinks and bends is consistent with damage during use.The cause of the reported insertion difficulty remains unknown.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ CURVE, ELE
• Common Device Name: DIAGNOSTIC EP CATHETER
• 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: 7697628
• Report Number: 3008452825-2018-00242
• Device Sequence Number: 1065585
• Product Code: DRF
• UDI-Device Identifier: 05414734201377
• UDI-Public: 05414734201377
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K002976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 401443
• Device Lot Number: 6298269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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