MAUDE Adverse Event Report: MEDTRONIC MEXICO EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number	EUP2510X
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a physician was attempting to use a euphora balloon dilatation device to treat a lesion in a patient.The lesion was a distal pda with 90% occlusion, with minimal tortuosity and minimal calcification.No damage was found with the packaging.There were no issues with removing the device from the hoop.Negative prep was performed.The euphora catheter was attempted to be used for pre-dilating the lesion, but it did not cross, so it was not deployed.There was no previously deployed stent.There was no resistance going into the body.Resistance was found when trying to remove the euphora balloon out of the guide catheter.After the euphora balloon was removed from the catheter, it was found that the balloon catheter was ¿broken¿.It was reported that the catheter/delivery system became deformed.No excessive force was used during delivery.The patient was stable during and after the case.No patient complications have been reported as a result of this event.No abnormalities were found with the anatomy.
Additional Manufacturer Narrative
Product analysis summary: several kinks were evident on the hypotube from 8cm to 99cm distal to the strain relief.The device returned with a detachment at the guidewire entry port.The exchange joint material was torn and uneven on both sides of the detachment site.A section of the support wire was visible distal to the detachment site.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 7812136
• Report Number: 9612164-2018-02155
• Device Sequence Number: 13959487
• Product Code: LOX
• UDI-Device Identifier: 00643169560000
• UDI-Public: 00643169560000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• 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): 11/21/2018

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: 11/15/2019
• Device Catalogue Number: EUP2510X
• Device Lot Number: 214409404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1