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

Model Number	NCEUP2512X
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	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Resistance was noted during withdrawal of the device.Excessive force was used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the device returned with a detachment on the hypotube 23.5cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.A kink was evident on the hypotube 4cm proximal to the detachment site.Deformation was evident to the distal tip.No other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An nc euphora rx ptca balloon catheter was attempted to be used to treat a severely tortuous, severely calcified lesion in the distal cx artery.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.Resistance was encountered when advancing the device and excessive forces was not used.It was reported that the shaft broke outside the body and that the physician was able to grasp the distal portion of the broken shaft and remove it from the body without injury.No patient injury was reported.

• 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: 9494347
• Report Number: 9612164-2019-05241
• Device Sequence Number: 1215466
• Product Code: LOX
• UDI-Device Identifier: 00643169395930
• UDI-Public: 00643169395930
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup,Followup
• Report Date (Section B): 03/04/2020

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: 10/03/2021
• Device Model Number: NCEUP2512X
• Device Catalogue Number: NCEUP2512X
• Device Lot Number: 218632428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 12/20/2019; 01/30/2020; 03/03/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/15/2020; 02/18/2020; 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR