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

Catalog Number EUP2530X

Device Problem Deflation Problem (1149)

Patient Problems Intimal Dissection (1333); Patient Problem/Medical Problem (2688)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the device returned loaded into a guide catheter and haemostatic valve.A guidewire was returned loaded in the device.It was not possible to remove the guidewire.Numerous kinks were evident along the hypotube.The transition tubing was kinked immediately proximal to the guidewire entry port.The balloon returned deflated with residue present inside.Necking and stretching was evident to the proximal balloon bond.It was not possible to inflate the balloon.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician was attempting to use a euphora rx balloon to treat a mid lad lesion.No damage noted to device packaging and no issues noted removing the device from the hoop / tray.The device was inspected with no issues noted.The lesion was pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No excessive force was used during delivery.There were no inflation difficulties.Forty % contrast: sixty % saline was used.It was reported that balloon deflation difficulties were encountered after the 1st inflation.The device would not deflate at the lesion site.The device was not moved or re-positioned prior to the deflation difficulties.It was reported that a dissection occurred as a result of this issue.The physician had to use an additional stent due to issues with the balloon.Tried several strategies to burst the balloon.It is reported that intervention was used to remove the device, but that was unsuccessful.Physician removed the balloon by pulling it out.No additional patient sequelae reported.

Manufacturer Narrative

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: 6492936
• MDR Text Key: 72782533
• Report Number: 9612164-2017-00446
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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
• Report Date: 03/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2018
• Device Catalogue Number: EUP2530X
• Device Lot Number: 212300096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• 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