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

Model Number NCEUP3015X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); Vascular Dissection (3160)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure an attempt was made to use one nc euphora rx ptca balloon catheter to treat a lesion located in the proximal left anterior descending (lad) artery.The device was inspected with no issues noted.The device was pre-dilated.The device did not pass through a previously deployed stent.It was reported that the balloon burst at 18 atms.It was also reported that balloon deflation difficulties occurred at the lesion site.The device was removed from the patient using a snare.The patient was reported to be alive with no injury.

Manufacturer Narrative

An image provided is of the distal section of a poba device with a detachment of the balloon and the inner member.The balloon appears to have detached at proximal balloon bond, this indicates the balloon ruptured at this location.Blood is visible in the balloon.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: mildly tortuous lesion exhibiting 70% stenosis located in the distal left anterior descending (lad) artery.Negative prep was performed with no issues noted.The lesion was pre-dilated with another balloon, and then stented using a resolute onyx (2.5mm) coronary drug eluting stent.Post dilation was carried out using the nceup3015x device.Resistance was noted when advancing the nceup3015x and excessive force was not used.The nceup3015x was not moved or repositioned in the lesion while inflated.Deflation difficulties were noted on the second inflation.There were no difficulties on previous inflations.The balloon deflated slowly and blood returned when aspirating from the inflation lumen.It was stated that the mid lad had a dissection proximal to the implanted onyx stent as a result of the nceup3015x balloon rupture.This dissection required implantation of another stent.The nceup3015x sheared off in the right radial artery and was removed using a gooseneck snare.The concentration of contrast/saline solution used was approximately 3:1.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: 10024911
• MDR Text Key: 189974076
• Report Number: 9612164-2020-01767
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169395855
• UDI-Public: 00643169395855
• 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
• Report Date: 06/29/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: NCEUP3015X
• Device Catalogue Number: NCEUP3015X
• Device Lot Number: 218902614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 05/06/2020; 06/18/2020
• Supplement Dates FDA Received: 05/07/2020; 06/29/2020
• Date Device Manufactured: 11/11/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 108