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

Model Number EUP3020X

Device Problems Burst Container or Vessel (1074); Material Deformation (2976)

Patient Problems Shock (2072); Vascular Dissection (3160)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the procedure an attempt was made to use one euphora rx ptca balloon catheter to treat a non-tortuous and non-calcified lesion located in the ostium cx.There were no abnormalities in relation to the anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was not performed.The device did pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the balloon was inflated after stent deployment.An image of the inflated balloon was described as being abnormal in shape on the proximal part of the balloon.This part was in the left main.It was informed that balloon burst occurred during inflation at 14 atm's.After inflation, there was a dissection and the patient had a cardiogen ic shock.After the procedure another euphora device from the same lot was inflated outside the patient and the balloon broke.The other devices from this lot have been removed from the shelf at the account.Patient status is alive.

Manufacturer Narrative

Additional information reported that the burst occurred on the first inflation and the device was not moved or repositioned prior to the burst device evaluation: the balloon returned with no blood visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, a leak was observed on the proximal balloon bond.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a longitudinal tear on the proximal balloon bond material.The balloon material was jagged and uneven at the tear site.Lead in scratches were not evident proximal or distal to the tear site.The balloon bond appeared stretched.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: an image was provided of what appears to be the complaint device inflated inside a stent for post dilation.Part of the device proximal to the balloon also appears inflated.The reported dissection is not visible in the image as contrast is not being administered to the vessel in this image.The reported burst was not visible in the image provided.There appears to be air in the balloon as the distal cone is not visible like the proximal cone and negative prep was not performed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the reported dissection was treated with a stent.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: 7888587
• MDR Text Key: 120693065
• Report Number: 9612164-2018-02432
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K143480
• 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,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Model Number: EUP3020X
• Device Lot Number: 214749122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• 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): Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 62