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

Catalog Number	EUP2012X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
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
One euphora rx ptca balloon catheter was attempted to be used to pre-dilate a mildly tortuous, mildly calcified lesion in the mid lad.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.Resistance was not encountered when advancing the device and excessive force was not used.The balloon was being used to pre-dilate.It was reported that the balloon ruptured during the first inflation, 3-5 atm's of pressure had been applied.There was a sudden drop in pressure.The device was then removed and the procedure was completed using a non-medtronic device.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis summary: the balloon returned with no blood visible in the balloon and inflation lumen.The device was placed in the water bath in order to aid inflation.The balloon failed negative prep.On pressurisation of the device, a leak was observed on the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a short longitudinal tear on the balloon working length located at the distal marker band.Lead in scratches were not evident to the tear site.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7577017
• Report Number: 9612164-2018-01362
• Device Sequence Number: 2364735
• Product Code: LOX
• UDI-Device Identifier: 00643169559882
• UDI-Public: 00643169559882
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/26/2018

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: 12/02/2019
• Device Catalogue Number: EUP2012X
• Device Lot Number: 214502072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 09/03/2018; 10/12/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 10/02/2018; 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1