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

Catalog Number	EUP2515X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	12/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: numerous kinks and stretching were visible on the distal shaft.The device returned deflated with blood and residue present inside the inflation lumen and balloon.Negative prep did not detect a leak possibly due to the residue in the inflation lumen.The device was placed in a waterbath to disperse the residue.On removal of the device negative prep confirmed the presence of a leak.On pressurization of the device a leak was detected; a short radial tear was visible on the working length of the balloon.The balloon material was jagged and uneven along the leak site.(b)(4).
Event or Problem Description
It was reported that the physician was attempting to use a euphora rx balloon to treat a moderately calcified and slightly tortuous proximal lad lesion.No damage noted to device packaging and no issues were noted when removing the device from the hoop/tray.The device was inspected and negative prep performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device to the lesion.It was reported that the device was inflated in the rca once with no issues.It was then delivered to the lad and inflated once.The balloon started losing pressure at 13 atms.The device was not moved or re-positioned prior to the burst.After the case, when the physician removed and attempted to re-inflate the balloon outside the body.He noticed a pin point hole that saline shot out of with substantial pressure.It was not a longitudinal split.The balloon caused a dissection.The physician put in two stents to cover.Patient is doing well.
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: 6253486
• Report Number: 9612164-2017-00048
• Device Sequence Number: 1027792
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2018
• Device Catalogue Number: EUP2515X
• Device Lot Number: 212232491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: 12/19/2016
• Initial Report FDA Received Date: 01/16/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention