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

Catalog Number	EUP2512X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician was attempting to use a euphora rx balloon to treat a moderately calcified and tortuous mid lad exhibiting 80% stenosis.No damage to device packaging and no issues removing the device from the hoop / tray.There were no difficulties encountered when removing the protective sheath or stylette.The device was inspected and negative prep performed with no issues noted.A 50/50 concentration of contrast/saline was used by the physician.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered during delivery and no excessive force used.No issues were noted during inflation of the device.It was reported that balloon deflation difficulties were encountered after the first inflation of the device, and the device would not deflate at the lesion site.The device was not moved or repositioned prior to the to the deflation difficulties.The physician removed everything together because the device could not deflate.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction, correct aware date of event is (b)(6) 2017.This date was confirmed on (b)(6) 2017.Evaluation summary: the device was returned loaded in the procedural guide catheter; it was not possible to remove the device from the catheter.The balloon was deflated when returned.The balloon bond was stretched and partially bunched.The balloon inflated slowly on pressurization of the device to 14 atms.Negative pressure was applied to the device; however, the balloon did not deflate.The distal tip was partially flattened.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: 6739769
• Report Number: 9612164-2017-00937
• Device Sequence Number: 1003126
• Product Code: LOX
• UDI-Device Identifier: 00643169560017
• UDI-Public: 00643169560017
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/22/2017

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: 04/21/2019
• Device Catalogue Number: EUP2512X
• Device Lot Number: 213164680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 06/23/2017; 08/22/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 08/09/2017; 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1