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

Catalog Number	NCEUP2506X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: balloon was returned partially inflated.No deformation/stretching to the balloon or balloon bond.The catheter burst 2.5cm proximal to the distal tip.Device was returned with blood present.Extreme stretching and twisting of the distal shaft was apparent during the visual inspection.Tear was present, along the distal shaft, 2.5cm proximal to the distal tip.Deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that a physician was using an nc euphora device to treat a non-tortuous and severely calcified lesion in the proximal cx artery.The physician was using the nc euphora balloon catheter to further expand a previously deployed non medtronic stent, that had been implanted 1 week previously.The previously implanted stent was determined to be under expanded by 50%.No damage was noted to the packaging and no issues were identified when removing the device from the hoop/tray.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre dilated.No resistance was noted during delivery of the device to the lesion, or during withdrawal of the device from the lesion.The device passed through the previously deployed stent.Excessive force was not used.It was reported that the previously deployed stent was not able to full expand when implanted.The patient was brought back for laser and further stent expansion was required due to heavy calcification of the vessel, and stenosis inside of the previously implanted stent.The nc euphora was inflated to 34 atm, and it was then noted that the shaft of the device became deformed and showed stretching, bunching and twisting.The balloon remained intact.No components of the device detached in the patient.No patient injury was reported.

• Brand Name: NC 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: 7127921
• Report Number: 9612164-2017-02005
• Device Sequence Number: 13909404
• Product Code: LOX
• UDI-Device Identifier: 00643169395954
• UDI-Public: 00643169395954
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• 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): 12/19/2017

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: 06/02/2019
• Device Catalogue Number: NCEUP2506X
• Device Lot Number: 213440818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR