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

Model Number EUP2015X

Device Problems Burst Container or Vessel (1074); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a procedure, a 6fr launcher guide catheter, a non-medtronic ivus catheter and a euphora rx ptca balloon catheter was used in a procedure to treat a severely tortuous and calcified lesion with 90% stenosis in the left circumflex artery.There was no damage noted to the launcher packaging.The launcher was inspected and prepped per ifu with no issues noted.Excessive force was not used during delivery.The launcher was excessively torqued.The ivus catheter became stuck when it was being removed from the guide catheter so the ivus catheter and the guide wire were removed together.It was indicated that it was possible that the inner lumen of the guide catheter was damaged as a result.The euphora device was inspected with no issues noted.Negative prep was performed with no issues noted.The device did not pass through a previously deployed stent.Resistance was encountered and excessive force was used.The euphora was inserted into the guide catheter after removing the non-medtronic ivus catheter.It was reported that resistance was experienced when trying to cross the lesion with the euphora which was being used to pre-dilate the lesion and the balloon ruptured on the first inflation.4 atm of pressure has been applied to the balloon prior to the burst.The device was not moved prior to the burst.It was indicated that they suspected that there was a possibility that the balloon was damaged due to the damaged carinain the inner of the guiding catheter at the time of the issue.The procedure was completed using an nc euphora device and the same launcher guide catheter.The patient is alive with no injury.

Manufacturer Narrative

Product analysis: the device returned with blood visible in the balloon.The balloon was deflated on return; the balloon folds were expanded.Deformation was evident to the distal tip, with the material appearing torn.There was no stretching evident to the proximal balloon bond.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a short longitudinal tear on the balloon distal cone.The balloon material was jagged and uneven at the tear site.Lead in scratches were evident proximal and distal to the tear site.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.

• Brand Name: 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: 8698914
• MDR Text Key: 149201855
• Report Number: 9612164-2019-02335
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Model Number: EUP2015X
• Device Catalogue Number: EUP2015X
• Device Lot Number: 215187114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2018
• 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