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

Catalog Number	EUP2515X
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: balloon returned deflated with traces of residue present inside the balloon.The distal tip and distal balloon cone were pulled into the balloon.Proximal balloon bond was stretched and slightly bunched.Kinks were evident on the distal shaft at 2.5cm, 17.2cm and 17.6cm proximal to the distal tip.Stretching was evident on the transition tubing.Negative prep was performed with no issue noted.The device failed to inflate deflation testing could not be performed.Inner lumen patency was verified with a 0.015 inch mandrel.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 euphora balloon catheter to treat a non -calcified and mildly tortuous distal cx lesion exhibiting 99% stenosis.It was reported that no damage was noted to the device packaging.No issues noted removing the device from the hoop/tray or when removing the protective sheath / packaging stylet from the device.The device was inspected and negative prep performed with no issues noted.The lesion was not pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered during delivery and no excessive force used.The 50/50 concentration of contrast / saline was used by the physician.Inflation difficulties (slow inflation) were noted at 8atm with slow contrast.It was reported that the balloon failed to deflate and was removed while still inflated.Device was not moved or re-positioned prior to the deflation difficulties.No intervention was used to remove the device.Wire and guide were removed with the balloon.No patient injury reported.

• 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: 6685280
• Report Number: 9612164-2017-00839
• Device Sequence Number: 11079480
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• 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
• Report Date (Section B): 06/05/2017

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: 03/23/2019
• Device Catalogue Number: EUP2515X
• Device Lot Number: 213012238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 07/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 73