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

Catalog Number	NCEUP3008X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
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 attempt was made to use one nc euphora rx ptca balloon catheter to treat a lesion.The device was inspected with no issues.Negative prep was performed with no issue.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery of the device.It was reported that during delivery through the vessel that the balloon catheter broke and detached.The distal end of the catheter was removed by removing the guide catheter.It was reported that the back end of the delivery shaft kinked but not where the delivery catheter broke.The patient is reported to be alive no injury.
Additional Manufacturer Narrative
Product analysis summary: the device returned with a detachment on the hypotube 70cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.Bends were evident on the hypotube 6.5cm proximal to the detachment site.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: 8045591
• Report Number: 9612164-2018-03086
• Device Sequence Number: 1473365
• Product Code: LOX
• UDI-Device Identifier: 00643169395879
• UDI-Public: 00643169395879
• 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): 01/22/2019

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: 08/08/2020
• Device Catalogue Number: NCEUP3008X
• Device Lot Number: 215990880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 01/12/2019
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1