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

Model Number	EUP3015X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician was attempting to use a euphora rx balloon to treat a mildly calcified and moderately tortuous mid lad lesion exhibiting 90 % stenosis.No damage to device packaging or issues removing the device from the hoop.No difficulties noted when removing the protective sheath / packaging stylette from the device.The device was inspected and negative prep performed with no issues noted.The lesion was pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered when advancing the device or excessive force used.There were no inflation difficulties.Pressure of 14 atm was applied.It was reported that usually a 50/50 concentration of contrast / saline is used however there could have been higher ratio of contrast drawn.The device failed to deflate at the lesion site on the first deflation.The device was not moved or repositioned prior to the deflation difficulties.The balloon and guide catheter were removed from the patient.No patient injury reported.
Additional Manufacturer Narrative
The device was returned for analysis.The balloon returned partially inflated with crystallised residue present inside the balloon and inflation lumen.The distal tip was pulled proximally into the balloon distal cone and deformed.The proximal inner shaft marker had moved proximally on the inner shaft.The proximal balloon bond was stretched and bunched.Kinks were evident along the distal shaft.The distal shaft was bunched and stretched.Deflation testing was not performed due to the deformation on the distal shaft and proximal balloon bond.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: 6556341
• Report Number: 9612164-2017-00573
• Device Sequence Number: 1088689
• Product Code: LOX
• UDI-Device Identifier: 00643169560154
• UDI-Public: 00643169560154
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2017

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: 11/24/2018
• Device Model Number: EUP3015X
• Device Catalogue Number: EUP3015X
• Device Lot Number: 212368801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: 07/15/2017; 07/15/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 08/11/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1