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

Catalog Number	NCEUP2020X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2019
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
During a procedure an attempt was made to use a nc euphora rx ptca balloon catheter to treat a moderately tortuous, severely calcified lesion located in the mid circumflex (cx) artery.The device was inspected with no issues.Negative prep was performed without issue.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used.It was reported that on the first inflation to 8 atm that a balloon burst occurred.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
No difficulties were noted when removing the device protective sheath or stylette prior to use.The device was not moved or repositioned in the lesion prior to the burst.Another nc euphora was used to complete the procedure.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: 9069669
• Report Number: 9612164-2019-03935
• Device Sequence Number: 1782155
• Product Code: LOX
• UDI-Device Identifier: 00643169396678
• UDI-Public: 00643169396678
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 10/17/2019

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: 01/27/2021
• Device Catalogue Number: NCEUP2020X
• Device Lot Number: 217019745
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1