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

Catalog Number	NCEUP27508X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Angina (1710); Vascular Dissection (3160)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It is reported that an nc euphora device had a micro hole when inflated, which may have caused a septal dissection.A small pinhole leak on the balloon caused contrast to leak out.The patient is reported as stable and has had some mild angina post case and is staying overnight in hospital.The rest of the case went well.
Additional Manufacturer Narrative
Additional information: it is noted that the patient has calcified arteries.A nc euphora balloon catheter was intended to be used.The target location was a lesion in the lad which was tortuous and calcified.The device was being used to pre-dilate the lesion.The device was inspected prior to use with no issues noted.Negative prep/purging was performed on the device prior to use with no issues noted.Resistance was noted while advancing the device to the lesion.No excessive force was used.3 inflations of 14 atm were used prior to the balloon burst.The balloon burst on the 3rd inflation at 14 atm.There was a sudden drop in pressure.No further balloons were used to pre-dilate after the balloon burst.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: 7127999
• Report Number: 9612164-2017-02012
• Device Sequence Number: 19288773
• Product Code: LOX
• UDI-Device Identifier: 00643169396111
• UDI-Public: 00643169396111
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2019
• Device Catalogue Number: NCEUP27508X
• Device Lot Number: 213493756
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR