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

Catalog Number	EUP1512X
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
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 balloon catheter was intended to be used to pre-dilate a mildly tortuous and moderately calcified lesion.There was no damage noted to the device packaging.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 a balloon burst occurred during the first balloon inflation.There was a sudden drop in pressure.The device was not moved or repositioned prior to the burst.The procedure was completed.No patient injury is reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Correction to aware date for previously submitted additional information.The correct aware date for report # 9612164-2018-01840 is the 15-nov-2018.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: 7713309
• Report Number: 9612164-2018-01840
• Device Sequence Number: 1328975
• Product Code: LOX
• UDI-Device Identifier: 00643169559837
• UDI-Public: 00643169559837
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 11/27/2018

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: 01/27/2019
• Device Catalogue Number: EUP1512X
• Device Lot Number: 215286538
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 11/15/2018; 11/15/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/22/2018; 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1