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

Model Number	NCEUP3515X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the device returned with blood visible in the balloon and inflation lumen and the balloon fold remained intact.The device failed negative prep.On pressurisation of the device, liquid was observed exiting the proximal portion of the distal shaft, therefore the device failed to maintain pressure.Upon visual inspection of the device, there was a small tear on the distal shaft material immediately proximal to the support wire.The distal shaft material was jagged and protruded upwards at the tear site.Kinking was also evident to the distal shaft and support wire.Deformation was evident to the distal tip.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use one nc euphora rx ptca balloon catheter to treat a moderately tortuous, mildly calcified lesion exhibiting 80% stenosis located in the proximal diagonal branch.There was no damage noted to the packaging.There was no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with issues noted.It was reported that during negative prep, the balloon was in the patients body and blood was aspirated in the inflation device.The balloon had not been inflated.It was stated that there was a leak coming from the shaft of the balloon.The balloon was removed from the patient when this was observed.The balloon was inflated following removal of the device from the body to identify the source of the leak.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Additional information: the leak occurred before the first balloon inflation.Blood was noticed in the barrel of the inflation device.The same inflation device was successfully used with other devices.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: 9804885
• Report Number: 9612164-2020-01067
• Device Sequence Number: 13647608
• Product Code: LOX
• UDI-Device Identifier: 00643169396333
• UDI-Public: 00643169396333
• 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,Followup,Followup
• Report Date (Section B): 04/16/2020

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: 04/29/2021
• Device Model Number: NCEUP3515X
• Device Catalogue Number: NCEUP3515X
• Device Lot Number: 217602848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/23/2020; 04/03/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/30/2020; 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 75