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	01/09/2018
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 sprinter otw balloon catheter was used to treat a heavily calcified rca lesion.The lesion had been previously stented.A euphora balloon catheter was also used.It was reported that he balloons were inflated to nominal and rated pressures when the balloons ruptured due to sharp calcium and/or stent struts which most likely impaled the balloons at the right rated atms.Multiple balloons were used and broke during use.Everything was removed from the body.There were no bad patient outcomes.
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: 7288218
• Report Number: 9612164-2018-00391
• Device Sequence Number: 1892997
• Product Code: LOX
• UDI-Device Identifier: 00643169559899
• UDI-Public: 00643169559899
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2018

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: 07/19/2019
• Device Catalogue Number: EUP2015X
• Device Lot Number: 213678629
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR