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

Catalog Number NCEUP3512X

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: a non poba stylette was partially loaded in the device.Deformation was evident to the distal tip, the material appeared accordioned.There was no damage evident to the proximal balloon bond.The stylette was removed using force.A 0.014inch mandrel was frontloaded and backloaded through the inner member with no issues noted.The inner member was verified with a 0.015inch mandrel.Negative prep was performed on the device and there was no evidence of a leak on the device.There was no other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.

Event Description

During a procedure it was intended to use a nc euphora rx ptca balloon catheter to treat a lesion.There was no damage noted to packaging.Difficulty and resistance was noted when removing the protective sheath and packaging stylette.The device was inspected with issues noted.On removal of the balloon from the package and removal of the stylette, there was damage noted at the tip of the balloon.It was also reported that the guide could not advance through the damage at the tip of the device.The device was not used in the patient.The patient is alive with no injury.

Manufacturer Narrative

Additional information: it has been subsequently reported that the non poba stylette that was noted to be partially loaded in the device during device evaluation may have been placed in the device by mistake when preparing the device for return.If information is provided in the future, a supplemental report will be issued.

• 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: 9097517
• MDR Text Key: 159360811
• Report Number: 9612164-2019-03998
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2021
• Device Catalogue Number: NCEUP3512X
• Device Lot Number: 217069710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 09/20/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 01/09/2020
• Date Device Manufactured: 02/05/2019
• 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