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

Catalog Number	EUP22512X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
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
The physician intended to use a euphora balloon catheter to treat a lesion located in the lad.No damage was noted to packaging and no issues were noted when removing the devices from the tray/hoop.The physician noted that it was difficult to remove the stylette.The devices were inspected and prepped with no issues identified.The lesion was pre-dilated.It was reported that deflation difficulties were encountered.The balloon would not deflate at the lesion site.The device did not pass through a previously deployed stent, resistance was not encountered when advancing the device and no excessive force was used during delivery.The indeflator was taken off the balloon catheter and the balloon was deflated with a syringe.No patient injury reported.
Additional Manufacturer Narrative
The device was returned for analysis.The stylette was not returned for analysis.The distal tip was stretched and deformed.The balloon bond was stretched.Balloon returned partially deflated.Kinks were evident on the hypotube.The balloon failed to deflate/ inflate due to the stretched 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.
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: 6646036
• Report Number: 9612164-2017-00769
• Device Sequence Number: 10994505
• Product Code: LOX
• UDI-Device Identifier: 00643169559950
• UDI-Public: 00643169559950
• 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,Followup
• Report Date (Section B): 10/17/2017

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: 02/17/2019
• Device Catalogue Number: EUP22512X
• Device Lot Number: 212814942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 06/30/2017; 06/30/2017; 09/20/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 07/28/2017; 09/07/2017; 10/17/2017
• 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