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

Model Number NCEUP2512X

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9494347
• MDR Text Key: 187961429
• Report Number: 9612164-2019-05241
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169395930
• UDI-Public: 00643169395930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR