MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION UNK DESTINATION; INTRODUCER, CATHETER

Model Number N/A

Device Problems Break (1069); Unraveled Material (1664)

Patient Problems Nerve Damage (1979); Pain (1994); Dizziness (2194); Dyskinesia (2363)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

Expiration date - unknown due to lot number being unknown.Udi - unknown due to lot number being unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to lot number being unknown.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The product lot number was unknown, which prevented a meaningful review of the device history record and complaint files.

Event Description

Terumo medical received a letter from a law office reporting that their client was allegedly injured as a result of the destination device sheath break.The user facility reported that the patient was being treated for right renal artery aneurysm in the angiogram department via endovascular means.They had to get both left femoral, as well as a left radial access.The sheath in the left radial artery broke when they were trying to snare it and bring it out of the left femoral artery.The sheath buckled, and there was a tight knot of the sheath, catheters, and snare in the left common femoral artery.It was reported that there was no safe way for removal.Therefore, the patient was then urgently sent to surgery for a cut down and removal of sheath, catheter, snare and to prevent thrombosis of her lower leg vessels.The surgery for removal was successful.The sheath, catheter and the snare were all removed during surgical intervention.Patient experienced a stroke during the course of the procedures which required rehabilitation, and alleged permanent impairment.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: UNK DESTINATION
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8345477
• MDR Text Key: 136447194
• Report Number: 1118880-2019-00022
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K091329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10FR VASCULAR SHEATH, VIABAND STENT ENSNARE DEVICE; 4MG DILAUDID, 900 UNITS HEPARIN; 4MG VERSED, 150MCG FENTANYL; 5MG VERAPAMIL, 400MCG NITROGLYCERIN, 50MG GRAVOL; CANTATA MICROCATHETER,7 FR SLENDER SHEATH; MPA CATHETER, BENTSON WIRE, GT MICROWIRE; MUSTANG HIGH PRESSURE BALLOON; TORNADO COILS, NESTER COILS, J TIIP GUIDEWIRE
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 52 YR