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

Catalog Number	EUP3020X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2017
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
The physician was attempting to use a euphora rx balloon to treat a non-calcified mid lad lesion.No damage was noted to device packaging and no issues removing the device from the hoop/tray.The device was inspected and negative prep performed with no issues noted.It was reported that the lesion was not pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered during delivery and no excessive force was used.It was reported that upon the first inflation, the device would not deflate at the lesion site.It was noticed immediately and the physician managed to walk the balloon out by deep seating the guide catheter.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: device was returned with guide catheter and loaded with 0.014inch guidewire.An y-connector also attached.The balloon was returned partially inflated.Kinking was evident along the hypotube and transitional shaft during initial inspection.Negative prep was performed, and device passed.It was not possible to inflate or deflate balloon.Deformation was visible during analysis along the distal shaft with numerous kinks and stretching.Deformation was evident to the distal tip.The inner lumen patency was not verified with a 0.015 inch mandrel due to kinking and stretching.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional device evaluation: the balloon bond is stretched and marker bands pulled proximal to original location due to stretching.Blood was visible throughout the device.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: 7211659
• Report Number: 9612164-2018-00128
• Device Sequence Number: 834313
• Product Code: LOX
• UDI-Device Identifier: 00643169560161
• UDI-Public: 00643169560161
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/03/2018

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: 07/29/2019
• Device Catalogue Number: EUP3020X
• Device Lot Number: 213746443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 02/05/2018; 02/05/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 03/06/2018; 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1