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

Catalog Number	EUP2512X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
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
During a procedure an attempt was made to use a euphora rx ptca balloon catheter to treat a non calcified lesion.There were no issues noted to the packaging and no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed without issue.The lesion was not pre-dilated.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that the balloon could not be inflated and contrast was observed to be leaking from the balloon immediately upon inflation attempt.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Product analysis summary: kinks were evident on the hypotube.There was no damage evident to the distal tip.The balloon folds were open, and the balloon was deflated.There was no damage evident to the proximal balloon bond.Crystallised contrast was visible in the balloon and inflation lumen.The device was placed in the water bath in order to disperse the contrast and aid inflation.Upon removal, the balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon working length.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a longitudinal tear on the balloon material directly above the proximal markerband.The tear appeared clean and there was no lead in scratches evident.There was 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: 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: 8748774
• Report Number: 9612164-2019-02615
• Device Sequence Number: 1998971
• Product Code: LOX
• UDI-Device Identifier: 00643169560017
• UDI-Public: 00643169560017
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• 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): 10/11/2019

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: 03/21/2021
• Device Catalogue Number: EUP2512X
• Device Lot Number: 217371292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1