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

Catalog Number	EUP3010X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 patient had stents previously implanted.An euphora balloon dilation catheter was being used to treat the rca.The lesion was moderately tortuous with 90% stenosis.There was no damage to the packaging and no issues removed the device from the hoop/tray.Device was inspected prior to use with no issues noted.Negative prep was not performed.The lesion was not pre-dilated.Device passed through a previous deployed stent.Resistance was experienced when advancing the device but it is unknown it excessive force was used.Balloon wasn't inflated.It is reported that during advancement of the device a break/fracture occurred on the mid shaft of the catheter.All parts of the device were successfully removed.The detached portion was pulled out by the shaft.The device was not kinked and restraightened during use.There is no patient injury.
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: 6459639
• Report Number: 9612164-2017-00367
• Device Sequence Number: 10881681
• Product Code: LOX
• UDI-Device Identifier: 00643169560130
• UDI-Public: 00643169560130
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• 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: 09/15/2018
• Device Catalogue Number: EUP3010X
• Device Lot Number: 211972158
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1