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

Model Number	EUP3020X
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Codes	Chest Pain (1776); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Date of Event	10/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the procedure an attempt was made to use one euphora rx ptca balloon catheter to treat a non- tortuous and mildly calcified lesion located in the proximal rca.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was predilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.Balloon deflation difficulties were reported and the device would not deflate at the lesion site.It was noted that the device was slow to inflate and only half the balloon was filled with contrast.After a 30 second inflation the balloon would not deflate.Patient reported feeling chest discomfort.The balloon was then overinflated to rupture and remove.This action caused a dissection, which was treated with a stent.No other injury occurred.
Additional Manufacturer Narrative
There were no difficulties noted when removing the protective sheath or packaging stylette from the device.The device was not moved or repositioned in the lesion.A 50/50 concentration of contrast / saline was used by the physician.Product analysis summary: a kink was evident on the distal inner 2.8cm proximal to the distal tip.The balloon returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the entire working length of the balloon.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a longitudinal tear on the balloon material from the proximal balloon cone to the distal balloon cone.The balloon material was jagged and uneven at the tear site.Lead in scratches were not evident proximal or distal to the tear site.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: 7973646
• Report Number: 9612164-2018-02795
• Device Sequence Number: 11173914
• Product Code: LOX
• UDI-Device Identifier: 00643169560161
• UDI-Public: 00643169560161
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2019
• Device Model Number: EUP3020X
• Device Catalogue Number: EUP3020X
• Device Lot Number: 213092756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention