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

Catalog Number	EUP3010X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: device was returned loaded on the guidewire inside the guide catheter.Balloon returned partially inflated with large traces of blood residue present inside the whole device.Device was removed from catheter and placed in waterbath to disperse blood residue.Numerous kinks were evident on the hypotube and also transition shaft, 0.1cm and 1.5cm proximal to the guidewire entry port.Negative prep was performed and inflation/deflation of balloon was performed.The balloon failed to inflate or deflate, due to proximal balloon bond being extremely stretched.A 0.015 inch mandrel did not advance through the inner lumen, due to stretching of balloon bond.Deformation of the distal tip was evident on visual inspection.Com: c50344.
Event or Problem Description
The physician intended to use a euphora balloon catheter to treat a tortuous lad with 90% stenosis.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.No difficulties were noted when removing the protective sheath from the device.No difficulties were recalled by the account when preparing the device.Negative prep was performed with no issues.The lesion was pre-dilated.No difficulties noted during the inflation of the device.During the procedure, balloon deflation difficulties occurred and the device would not deflate at the lesion site.A non-mdt inflation device was used and it was replaced with a new non-mdt inflation device.However, this did not work.It is reported that the physician pulled the balloon back into the guide catheter and took the entire system out after several attempts to deflate balloon.Deflation difficulties were noted after the first inflation.The device was not moved or repositioned prior to the deflation difficulties.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.A 50/50 concentration of contrast/saline was used by the physician.There is no patient injury.

• 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: 6787435
• Report Number: 9612164-2017-01090
• Device Sequence Number: 149550
• Product Code: LOX
• UDI-Device Identifier: 00643169560130
• UDI-Public: 00643169560130
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/14/2017

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: 02/17/2019
• Device Catalogue Number: EUP3010X
• Device Lot Number: 212814768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1