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

Model Number	401890
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During an electrophysiology (ep) procedure device entanglement occurred.At the start of the case the supreme ep catheter was introduced into the patient through the right femoral vein.The ep catheter was then moved to the left femoral vein in order to introduce the ablation catheter.The ep catheter was inserted into the 5fr sheath in the left femoral vein but would not reach the heart.Under fluoroscopy the catheter appeared to have looped into a knot.Following unsuccessful attempts to undo the knot the procedure was continued with the ep catheter in the left femoral vein and a new ep catheter was placed via a separate left sided venous access.When the procedure was completed the user attempted to remove the knot again but when it still could not be undone the entire system of the sheath and catheter were removed as a single unit.The removal of the sheath and catheter had no adverse impact on the patient.A routine suture stitch was used to close the access site and manual pressure was applied for 10 minutes.There were no adverse patient consequences.
Additional Manufacturer Narrative
One supreme ep catheter was received for evaluation.The reported knot in the catheter shaft was confirmed.No other anomalies in the catheter shaft were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the knot in the shaft is consistent with damage during use.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN¿ 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: 8888390
• Report Number: 3008452825-2019-00409
• Device Sequence Number: 2876661
• Product Code: DRF
• UDI-Device Identifier: 05414734201667
• UDI-Public: 05414734201667
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/21/2019

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: 02/28/2022
• Device Model Number: 401890
• Device Lot Number: 6906618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 76