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

Catalog Number EUP2015X

Device Problems Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017)

Patient Problem Thrombus (2101)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) protector.

Event Description

It was reported that the physician was attempting to use a euphora rx balloon to treat a moderately tortuous distal cx lesion.No damage noted to packaging or issues noted removing the device from the hoop/tray.The device was inspected with no issues noted.During the procedure it was noted that the balloon could not be inflated.The protective sheath on the tip of the balloon was inserted into the body, along with the balloon itself.Resistance was encountered when advancing the device but no excessive force used.The balloon ((b)(4)) was discarded.The protective sheath remains in the body.The patient experienced foreign body thrombosis.It is reported that the patient is ok.

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: 6056636
• MDR Text Key: 58354760
• Report Number: 9612164-2016-01125
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143480
• 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
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EUP2015X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• 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): Hospitalization