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

Catalog Number	NCEUP2515X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
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 attempt was made to use one nc-euphora rx ptca balloon catheter to treat a moderately tortuous and calcified lesion exhibiting 90% stenosis located in the mid obtuse marginal (om).The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was not pre-dilated.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that a balloon leak occurred on the first inflation while inflating to 12atm.It is indicated that there was a hole in the balloon prior to inflating the device.The patient is reported to be alive with no injury.
Additional Manufacturer Narrative
The balloon was intended to be used for pre-dilation.The device was not moved or re-positioned prior to the inflation difficulties.The same inflation device was successfully used with other devices before and after the inflation difficulties were encountered.Another balloon of the same size was used to complete the procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the device returned with crystallised contrast visible in the balloon and inflation lumen.The device was placed in the waterbath to disperse the contrast in order to aid inflation.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting 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 at the distal cone.There was no lead in scratches visible surrounding the tear site.The material at the tear site was protruding outwards.No other damage evident to the remainder of the device.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: 8072909
• Report Number: 9612164-2018-03205
• Device Sequence Number: 2262386
• Product Code: LOX
• UDI-Device Identifier: 00643169396159
• UDI-Public: 00643169396159
• 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,Followup,Followup
• Report Date (Section B): 02/12/2019

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: 08/10/2020
• Device Catalogue Number: NCEUP2515X
• Device Lot Number: 216006534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/14/2018; 02/08/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 11/27/2018; 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 72