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

Catalog Number NCEUP4020X

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Occlusion (1984); Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 08/12/2019

Event Type  Injury  

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 used to treat a mildly tortuous, moderately calcified lesion in the proximal left main coronary artery.The device was inspected with no issues.Negative prep was performed with no issues.The device passed through a previously deployed stent.Resistance was not encountered.Excessive force was not used during delivery.The device was not kinked and re straightened.It was reported that the catheter ruptured during balloon inflation at 20atm.It was reported that the device shaft detached/ruptured on inflation and part of the shaft remained in the patient.Several attempts were made with snares and other devices to catch the balloon material in the vessel.It was reported that the vessel was occluded and the patient was sent to acute bypass surgery.The patient was reported as alive.

Manufacturer Narrative

Device evaluation: there was a detachment of a section of the distal shaft and the balloon material.The material at the detachment site was jagged and uneven.The detached section of the distal shaft and balloon were not returned.There was no other damage evident to the remainder of the device.Image review: images show a lesion in the lad.A balloon is delivered to the lesion and the lesion is pre dilated.Further pre-dilations are performed.Images show the lesion following pre dilation.A stent is delivered to the lesion and deployed.The stent is post dilated.A portion of the distal shaft inflates during post dilation.The inflated portion of the distal shaft ruptures during inflation.Contrast images show occlusion of flow to the lad following rupture of the device.The marker bands of the post dilation balloon are visible inside the previously deployed stent, suggesting difficulty removing this portion of the device.Attempts are made to retrieve the device.Contrast images show occlusion of the lad.A final contrast image of the rca is shown and the procedure is ended.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: 8920133
• MDR Text Key: 155174637
• Report Number: 9612164-2019-03521
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: NCEUP4020X
• Device Lot Number: 215954062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR