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

Model Number	EUP2512X
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 a euphora rx ptca balloon catheter to treat a lesion.The lesion was pre-dilated.The device was inspected and negative prep was performed prior to use with no issues noted.There were no issues noted when removing device from the hoop.The device did pass through a previously deployed stent.No resistance noted advancing the device to the lesion and no excessive force was used.It was reported that normal balloon inflation was carried out.Deflation issues occurred leading to removal difficulties.The inflated balloon was pulled back into the guide catheter and removed.No patient injury reported.
Additional Manufacturer Narrative
No difficulties were noted when removing the protective sheath or packaging stylette from the device.The euphora was to be used in a previously implanted unknown brand stent that had in-stent restenosis.The deflation issue occurred after the first inflation attempt.The balloon would not deflate.50/50 contrast/saline was used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the tip appears to have been pull inwards into the balloon.The proximal markerband was positioned in the balloon bond and the distal markerband was positioned at the proximal balloon cone.Stretching is evident to the balloon bond.It was not possible to inflate the balloon and perform deflation testing due to the condition of the returned device.No 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: 7922839
• Report Number: 9612164-2018-02586
• Device Sequence Number: 1526528
• Product Code: LOX
• UDI-Device Identifier: 00643169560017
• UDI-Public: 00643169560017
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 01/26/2020
• Device Model Number: EUP2512X
• Device Lot Number: 214790464
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/02/2018; 01/04/2019
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/15/2018; 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1