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

Catalog Number	NCEUP2512X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was returned with blood visible in the balloon and inflation lumen.Device was placed in waterbath to disperse residue.Numerous kinks were evident throughout hypotube.A 0.014 inch mandrel failed to pass through hypotube due to extreme kinks.In order to inflate balloon, device was cut, 0.5cm distal to guidewire entry port.The balloon failed negative prep.On pressurisation of the device a short radial tear was observed along the balloons working length.The balloon material appeared to be uneven along the length of tear site.The inner lumen patency was verified with a 0.015 inch mandrel.No deformation was evident to the distal tip on visual inspection.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
Physician intended to use an nc euphora balloon catheter to treat a moderately calcified and moderately tortuous lesion in the distal circumflex with 100% chronic total occlusion.There was an anatomical abnormality in that the origin of the circumflex is from the rca.The device was inspected with no issues noted.Negative prep was performed with no issues.There was no damage noted to packaging and there were no issues when removing the device from the hoop/tray.The lesion was predilated and the device passed through a previously deployed stent.The physician observed that there was resistance and excessive force was not used.When the balloon was inflated at 16atm there was balloon burst, leak or catheter leak.The device was moved/repositioned in the lesion prior to the burst and the burst occurred on a subsequent inflation.While the balloon was inflating, blood was observed.The status of the patient is unknown.

• 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: 6833494
• Report Number: 9612164-2017-01199
• Device Sequence Number: 10780295
• Product Code: LOX
• UDI-Device Identifier: 00643169395930
• UDI-Public: 00643169395930
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/02/2017

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: 11/10/2018
• Device Catalogue Number: NCEUP2512X
• Device Lot Number: 212272457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1