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

Catalog Number	EUP2015X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The device returned with the balloon deflated and with blood residue visible in the inflation lumen.Initial negative purge did not identify a leak most likely due to the presence of blood or hardened contrast it the inflation lumen.Soaking and post pressurisation of the balloon and repeat negative purge confirmed the leak/burst.Upon pressurisation of the device, a leak was observed on the balloon.Upon visual inspection, a short longitudinal tear was observed on the balloon, starting at the midpoint of the balloon to the distal cone.Damage was evident to the balloon material, proximal to the tear.The proximal end of the tear there had a jagged edge on the balloon material.Stretching was evident to the balloon bond.Deformation was evident to the distal tip.
Event or Problem Description
It was reported that the physician was attempting to use a euphora rx balloon to pre-dilate a severely calcified, moderately tortuous lad lesion.It was reported that no damage was noted to the device packaging and no issues removing the device from the hoop/tray.The device was inspected with no issues noted.The lesion was pre-dilated.During the procedure, no resistance was encountered while advancing the device and no excessive force used.It was reported that at nominal pressure, the balloon ruptured on the 2nd inflation.There was a gradual drop in pressure.The balloon was re-positioned prior to the burst.No patient injury reported.The procedure was completed with an nc euphora of the same size.

• 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: 6685344
• Report Number: 9612164-2017-00840
• Device Sequence Number: 1236512
• Product Code: LOX
• UDI-Device Identifier: 00643169559899
• UDI-Public: 00643169559899
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 06/05/2017

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: 11/19/2018
• Device Catalogue Number: EUP2015X
• Device Lot Number: 212314138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 07/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1