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

Catalog Number	EUP3015X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a nc euphora balloon to pre-dilate a moderately calcified and non-tortuous proximal lad lesion exhibiting 99% stenosis.No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray.The device was inspected with no issues noted.No difficulties were noted when removing the protective sheath / packaging stylette from the device.Negative prep was performed with no issues.It was reported that contrast was initially spilled on the drape and the rn aspirated the contrast into a 30 cc syringe and then used that syringe to prep the balloon.The 30/70 contrast/saline was used.No gauze or drape fibre was noted in the contrast.The physician noted that the balloon was accidentally kinked while loading on the wire.The lesion was pre-dilated.It was reported that the balloon did not pass through a previously deployed stent.No resistance was encountered during delivery and no excessive force used.It was reported that inflation difficulties were encountered with slow inflation noted.Balloon deflation difficulties were also encountered after the first inflation.The device was not moved or repositioned prior to the deflation difficulties.The physician attempted to pull negative prep several times without success.The inflation balloon was pulled as much as possible into the guide catheter and then everything was removed from the vessel.The physician completed the procedure using three stents.No patient injury reported.The same inflation device was successfully used with other devices.
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: 6289265
• Report Number: 9612164-2017-00087
• Device Sequence Number: 16348058
• Product Code: LOX
• UDI-Device Identifier: 00643169560154
• UDI-Public: 00643169560154
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 01/05/2017

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: 11/03/2018
• Device Catalogue Number: EUP3015X
• Device Lot Number: 212239573
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: 01/05/2017
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1