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

Catalog Number	EUP27520X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); No Consequences Or Impact To Patient (2199); Stenosis (2263)
Date of Event	06/27/2018
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
A euphora rx balloon catheter was intended to be used to pre-dilate a moderately tortuous, severely calcified, eccentric lesion with 85% stenosis in the mid rca.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.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that the balloon burst on the first inflation after 12 atm of pressure had been applied.The device was not moved or repositioned prior to the burst.Immediate angiography revealed contrast in the coronary artery.Low pressure was noted.There was an attempt to re-inflate the balloon further.The lesion was thought to be sufficiently dilated, and the procedurewas completed with a resolute onyx stent.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis summary: the balloon returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, a leak was observed on the working length of the balloon.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a pinhole leak on the working length of the balloon material.The balloon material was jagged and uneven at the leak 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: 7710753
• Report Number: 9612164-2018-01825
• Device Sequence Number: 19086558
• Product Code: LOX
• UDI-Device Identifier: 00643169560109
• UDI-Public: 00643169560109
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/04/2018

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: 02/23/2019
• Device Catalogue Number: EUP27520X
• Device Lot Number: 212846539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 07/31/2018; 08/08/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/28/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR