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

Model Number	NCEUP3012X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2019
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.The device was inspected with no issues noted.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used during delivery.It was reported that a balloon burst/leak occurred during the first inflation at 17-18 atm.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis # (b)(6): device was returned for evaluation.The device returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.Upon visual inspection of the device, there was a large radial tear to the proximal balloon bond.The balloon material was jagged and uneven at the tear site.It was not possible to inflate the device.No other damage evident to the remainder of the device 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: 9568143
• Report Number: 9612164-2020-00161
• Device Sequence Number: 19366380
• Product Code: LOX
• UDI-Device Identifier: 00643169395862
• UDI-Public: 00643169395862
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2021
• Device Model Number: NCEUP3012X
• Device Catalogue Number: NCEUP3012X
• Device Lot Number: 218763529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1