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

Model Number	NCEUP3512X
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/13/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient had previous pci with implantation of a non-medtronic drug eluting stent.During the procedure an attempt was made to use one nc euphora rx ptca balloon catheter to treat a severely tortuous and calcified lesion located in the lm artery.The nc euphora was being used for post-dilation.No damage was noted to packaging.No issues were noted when removing the device from the hoop.The device was inspected.Negative prep was performed.There were no abnormalities in relation to the anatomy.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the balloon detached from the shaft in the distal lm to lad during removal.The device was not kinked and re-straightened during use.The patient was stable.The patient had surgery and all of the balloon was recaptured from the body.It was reported that the patient expired in recovery 5 days post index procedure, on the (b)(6) 2018.There is no cause of death available at this time.There was no evidence of restenosis or thrombus.The vessel was patent, visible.The patient was on dapt at the time of the event.
Additional Manufacturer Narrative
Product analysis summary: the device returned with a detachment on the transition tubing 109cm distal to the strain relief.A portion of the support wire was exposed 13.5cm distal to the detachment site.The transition tubing material was oval and jagged on both sides of the detachment site.A kink was evident on the transition tubing 37.1cm proximal to the distal tip.Deformation was evident to the distal shaft 4cm proximal to the distal tip with the material appearing kinked and flattened.Damage was evident to the guide wire entry port and the transition tubing immediately proximal to the guide wire entry port with the material appearing torn.A second nc euphora device was returned with the complaint device.There was no complaint allegation against the second nc euphora 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.

• 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: 7843845
• Report Number: 9612164-2018-02282
• Device Sequence Number: 11154321
• Product Code: LOX
• UDI-Device Identifier: 00643169396340
• UDI-Public: 00643169396340
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2020
• Device Model Number: NCEUP3512X
• Device Lot Number: 215386809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/12/2018; 12/14/2018
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 10/10/2018; 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention