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

Catalog Number	NCEUP4012X
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2018
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 nc euphora rx balloon catheter was intended to be used to treat a lesion located in the mid left anterior descending (lad) artery.The lesion was mildly tortuous and moderately calcified.No damage was noted to packaging.No issues were noted when removing the device from the hoop.The device was inspected with no issues found.Negative prep was performed with no issues.The lesion was pre-dilated.It was reported that a non-medtronic stent was implanted in the lad.The physician tried to advance the nc euphora balloon to the lesion site but felt some resistance.It was then attempted to pull the balloon out, but tension was felt when trying to remove the balloon and the catheter broke in half.The device did not pass through a previously deployed stent.No excessive force was used during delivery.The detached portion of the device was successfully removed from the patient.No intervention was required to remove the device from the patient.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the device returned with a detachment on the hypotube 54cm distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.Kinks were evident on the hypotube 2cm and 3.5cm proximal to the detachment site.The distal tip was flared.No deformation to the balloon.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: 7316566
• Report Number: 9612164-2018-00445
• Device Sequence Number: 1317065
• Product Code: LOX
• UDI-Device Identifier: 00643169396227
• UDI-Public: 00643169396227
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/05/2018

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: 09/12/2019
• Device Catalogue Number: NCEUP4012X
• Device Lot Number: 214006557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR