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

Catalog Number	NCEUP3015X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2018
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 nc euphora balloon catheter was attempted to be used to treat a mildly tortuous, severely calcified lesion in the mid lad - diagonal branch.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.Resistance was not encountered when advancing the device.Excessive force was not used.It is reported that the balloon burst on the first inflation after 12 atm of pressure had been applied while being used to re-dilate a re-stenosed stent.No patient complications reported for this event.
Additional Manufacturer Narrative
The re-stenosed stent was a non-medtronic stent.The device was not moved or repositioned prior to the burst.There was a slow drop in pressure.It wasn't until negative pressure was pulled that blood in the inflation device was noted.A compliant non-medtronic balloon was used to complete the procedure.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: NC 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: 7731331
• Report Number: 9612164-2018-01894
• Device Sequence Number: 16548870
• Product Code: LOX
• UDI-Device Identifier: 00643169395855
• UDI-Public: 00643169395855
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• 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): 10/03/2018

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: 02/23/2020
• Device Catalogue Number: NCEUP3015X
• Device Lot Number: 214969823
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 08/08/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/25/2018; 10/03/2018
• 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