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

Catalog Number	EUP2520X
Medical Device Problem Codes	Deflation Problem (1149); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2018
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 euphora rx ptca balloon catheter to treat a moderately tortuous, mildly calcified lesion exhibiting 85% stenosis located in the mid rca.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.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.It was reported that the balloon would not deflate at the lesion site following the first inflation.The balloon was removed through the guide catheter.The patient is reported to be alive with no injury.
Additional Manufacturer Narrative
No difficulties were noted when removing the protective sheath and packaging stylette.There was no difficulties noted during inflation of the device.The device was not moved or repositioned prior to the deflation difficulties.50/50 concentration of contrast / saline was used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the balloon returned partially inflated with crystallised residue visible in the balloon and inflation lumen.The proximal markerband was positioned in the proximal balloon pillow and the distal marker band was not positioned correctly due to stretching of the inner member.Stretching was evident to the proximal balloon bond.Negative prep was performed with no issues noted.It was not possible to perform inflation and deflation testing due to stretching of the proximal balloon bond.When inserting the patency mandrel through the distal tip, resistance was noted at the tip, on removing the mandrel the tip became stretched.No other damage was 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: 8159143
• Report Number: 9612164-2018-03592
• Device Sequence Number: 14002855
• Product Code: LOX
• UDI-Device Identifier: 00643169560031
• UDI-Public: 00643169560031
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 01/29/2019

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: 07/17/2020
• Device Catalogue Number: EUP2520X
• Device Lot Number: 215866337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 01/19/2019; 01/19/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/29/2019; 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR