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

Catalog Number	EUP2512X
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a euphora balloon to treat a non-calcified and non-tortuous mid lad lesion exhibiting 80% stenosis.No issues removing the device from the hoop/tray.The physician removed the device from the hoop then wiped it down with saline to activate the coating.Significant force was required to remove the stylet.The device was inspected and negative prep performed with no issues noted.The lesion was pre-dilated.No difficulties were noted during inflation of the device.The device was not moved or re-positioned prior to the deflation difficulties.A 50/50 concentration of contrast/saline was used.During the procedure the device did not pass through a previously deployed stent.No resistance was encountered during delivery and no excessive force used.It was reported that the balloon would not initially deflate at the lesion site after the first inflation.The device then deflated just enough to pull it back out of the artery and out of the guide while still remaining partially inflated throughout.No patient injury reported.
Additional Manufacturer Narrative
The stylette was removed from the distal tip when returned.Blood residue was visible inside the inflation lumen.Balloon returned deflated with traces of residue inside the balloon.The distal tip was slightly flared.The balloon bond was stretched and kinked.Numerous kinks were evident on the hypotube.The distal balloon cone was pulled distally over the distal tip.The balloon could not be inflated due to stretching at the balloon bond.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.

• 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: 6749216
• Report Number: 9612164-2017-00959
• Device Sequence Number: 16373699
• Product Code: LOX
• UDI-Device Identifier: 00643169560017
• UDI-Public: 00643169560017
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2017

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: 04/19/2019
• Device Catalogue Number: EUP2512X
• Device Lot Number: 213157534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 08/22/2017; 09/20/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 09/20/2017; 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-3136-2017
• Patient Sequence Number: 1
• Patient Age: 79 YR