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

Catalog Number	EUP3015X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2019
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 and attempt was made to use a euphora rx ptca balloon catheter and a nanocross 0.14 otw pta dilatation catheter to treat a moderate calcified, moderate tortuosity lesion exhibiting 100% chronic total occlusion in the mid right tibial/popliteal trunk.The euphora balloon was inspected with no issues noted, negative prep was performed on the euphora balloon with no issues.The lesion was not pre dilated.The device did not pass through a previously deployed stent.Resistance was not encountered, excessive force was not used.No embolic protection was used on the nanocross 0.14 otw.There was no issues noted removing nanocross 0.14 otw from the hoop/tray.The nanocross 0.14 otw was prepped as per the ifu with no issues noted.It is reported that both balloons burst/ruptured on the initial inflation at approx.8atm.The patient is alive with no injury.
Additional Manufacturer Narrative
Device evaluation summary: the balloon was deflated, the balloon folds were expanded.Blood was visible in the inflation lumen.Deformation was evident to the distal tip, with the material bunched and torn.There was no stretching evident to the proximal balloon bond.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon distal cone material.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a burst site on the balloon material immediately distal to the distal markerband.There was no lead in scratches evident proximal or distal to the burst site.There was no other damage evident to the remainder of the device.Image review: one set of 3 images were received for analysis.The image on the left shows the reported lesion and a guide wire positioned across the popliteal/tibial artery.The central image shows an inflated balloon in the lesion.The image on the right shows the lesion.There is no evidence of a balloon burst from the set of images.An image was received showing the guide wire positioned across the popliteal/tibial artery.There is no evidence of balloon burst in the returned still images.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Neither device was repositioned during inflation.A non-medtronic inflation device was used for all balloons.A non-medtronic balloon was used to complete the procedure.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: 8649022
• Report Number: 9612164-2019-02056
• Device Sequence Number: 16676809
• Product Code: LOX
• UDI-Device Identifier: 00643169560154
• UDI-Public: 00643169560154
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2019

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: 01/28/2021
• Device Catalogue Number: EUP3015X
• Device Lot Number: 217028619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 05/18/2019
• Supplement Date Received by Manufacturer: 06/01/2019; 07/24/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/01/2019; 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 96