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

Catalog Number	NCEUP3015X
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	07/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.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 an nc euphora rx balloon catheter to treat a lesion located in the proximal ramus.The target lesion was moderately tortuous, severely calcified with 99% stenosis.No damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected, with no issues found.Negative prep was also performed with no issues encountered.The lesion was not pre-dilated.It was reported that detachment of the balloon catheter occurred inside the guide catheter during advancement through guide catheter.Resistance was not encountered when advancing the device but excessive force was used during delivery.The device was not kinked and re-straightened during use.The stent did not pass through a previously deployed stent.The detached portion was removed with the 6f guide catheter.The balloon and guide catheter were both removed together.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary: the hypotube had detached 84.8 cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.Numerous kinks were evident on the hypotube proximal and distal to the detachment site.Slight deformation was evident to the distal tip.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: 6793674
• Report Number: 9612164-2017-01105
• Device Sequence Number: 139541
• Product Code: LOX
• UDI-Device Identifier: 00643169395855
• UDI-Public: 00643169395855
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/08/2017

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: 02/08/2019
• Device Catalogue Number: NCEUP3015X
• Device Lot Number: 212753785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 07/17/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 09/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR