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

Catalog Number	NCEUP2515X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
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
It was reported that the physician intended to use two nc euphora rx ptca balloon catheters to treat a mildly tortuous and severely calcified lesion located in the mid left anterior descending artery.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray for the first device (lot no:213084941).The devices were inspected and negative prep was performed with no issues noted.The devices were being used to pre-dilate the lesion.The devices did not pass through a previously-deployed stent.Resistance was not encountered when advancing the devices and excessive force was not used during delivery.It was reported that both balloons burst during balloon inflation at 17 atm¿s.The devices were not moved or repositioned prior to the burst.There was no sudden or gradual pressure drop noted on the inflation device.The bursts occurred during the first inflation.The lesion was treated with orbital atherectomy prior to balloon angioplasty with the two nc euphora balloons the physician completed the procedure by using orbital atherectomy with non mdt device and angioplasty procedure was completed.No stenting was completed in the procedure as a non-mdt stent failed to cross.Patient status post-procedure is alive with no injury.
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: 7177741
• Report Number: 9612164-2018-00041
• Device Sequence Number: 13756213
• Product Code: LOX
• UDI-Device Identifier: 00643169396159
• UDI-Public: 00643169396159
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/10/2018

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: 04/05/2019
• Device Catalogue Number: NCEUP2515X
• Device Lot Number: 213084941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR