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

Catalog Number	NCEUP3515X
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An nc euphora rx balloon catheter was being used to treat a lesion located in the left anterior descending (lad) artery.No damage was noted to packaging, i.E.Shelf carton, hoop/tray and no issues were noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was performed with no issues.It was reported that during balloon inflation the balloon burst/ leaked.Low pressure was applied.Zero inflations were applied to the device prior to the issue occurring.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device and excessive force was not used during delivery.There was no patient injury reported.
Additional Manufacturer Narrative
Evaluation summary: the balloon returned with contrast in the balloon and inflation lumen.The balloon failed negative prep.The distal shaft was kinked 17.5cm proximal to the distal tip.On pressurisation of the device, a leak was observed on the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a short longitudinal tear on the balloon material immediately proximal to the balloon distal cone.The balloon material was jagged and uneven at the tear site.The distal tip was stubbed.If information is provided in the future, a supplemental report will be issued.

• 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: 7265889
• Report Number: 9612164-2018-00342
• Device Sequence Number: 16623741
• Product Code: LOX
• UDI-Device Identifier: 00643169396333
• UDI-Public: 00643169396333
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 03/21/2018

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: 08/04/2019
• Device Catalogue Number: NCEUP3515X
• Device Lot Number: 213778430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1