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

Model Number EUP22510X

Device Problems Deflation Problem (1149); Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A euphora ptca balloon catheter was attempted to be used to treat a non-tortuous, mildly calcified lesion with 75% stenosis in the mid diagonal branch of the lad.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The balloon was advanced to the lesion.The balloon was inflated to 6atm and slipped distal to the lesion without dilation.Deflation was attempted.It is reported that the balloon would not deflate at the lesion site following the first inflation.The indeflator was changed.Aspiration was attempted with a 20ml syringe.The device remained inflated and did not move back when pulled.An attempt was made to puncture the balloon with the guidewire but it was unsuccessful.The balloon was then pulled forcefully into the guide catheter, and there was a concern that this could lead to a traumatic atherectomy in the coronary artery.When the balloon was removed from the guide catheter it was still inflated.Deflation was attempted again with the indeflator, but the balloon remained inflated.It was reported that there was no patient injury.

Manufacturer Narrative

Additional information: patient's age -(b)(6) years.Patient's weight - (b)(6)'s.Concentration of contrast/saline - 50%/50% prior to use, no difficulty was noted when removing the protective sheath stylette.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

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: 7950908
• MDR Text Key: 123380551
• Report Number: 9612164-2018-02685
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K141090
• 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,Followup
• Report Date: 02/06/2019

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: 09/08/2019
• Device Model Number: EUP22510X
• Device Catalogue Number: EUP22510X
• Device Lot Number: 213980726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 10/11/2018; 02/06/2019; 02/06/2019; 02/06/2019
• Supplement Dates FDA Received: 11/09/2018; 02/06/2019; 02/06/2019; 02/06/2019
• Date Device Manufactured: 09/08/2017
• 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: 84 YR
• Patient Weight: 60