MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD-2¿ CURVE, E; DIAGNOSTIC EP CATHETER

Model Number	401860
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis; however, one image was provided for evaluation.Based solely on the aforementioned image, the catheters appeared to be caught with each other at the distal end of the shaft.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported entanglement remains unknown.
Event or Problem Description
Related manufacturing ref: 3005334138-2018-00206.During the procedure, the mapping and fixed curve catheters became entangled around an inferior vena cava filter (ivc) filter from the groin.The ivc filter was snared with a device from a superior ij access site.Once the ivc filter was secured with the snare device, the entangled catheters were freed from the ivc filter.The filter was then completely extracted using the snare and a sheath from the superior access.The handle of the fixed catheter was cut off as it was still entangled in the mapping catheter and both devices were removed via an introducer.

• Brand Name: SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD-2¿ CURVE, E
• 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: 7684831
• Report Number: 3008452825-2018-00236
• Device Sequence Number: 13816201
• Product Code: DRF
• UDI-Device Identifier: 05414734201513
• UDI-Public: 05414734201513
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K002976
• 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): 07/13/2018

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: 02/28/2021
• Device Model Number: 401860
• Device Lot Number: 6349215
• 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: 06/20/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ HD GRID MAPPING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR