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

Catalog Number EUP27510X

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)

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

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis.There were numerous kinks visible along the hypotube.The balloon and tip material along with the inner shaft markers had detached.The balloon bond was not visible indicating that it had detached along with the balloon material.A section of the inflated distal outer shaft remained.The distal outer material was jagged and uneven at the detachment site.The inner shaft was stretched.The inner shaft material was jagged and uneven at the detachment site.Cine review: four still images were received from the account which appear to show the lesion site in the 1st diagonal.The images do not capture use of the euphora device and therefore do not confirm the reported event.

Event Description

It was reported that the physician was attempting to use one euphora rx balloon catheter to treat a lesion in the lad vessel.Lesion exhibited moderate calcification and tortuosity.The device was inspected with no issues noted.Negative prep was performed successfully.Lesion was dilated with the a euphora balloon(2.75x10).No resistance was noted while advancing to the lesion.It was reported that during first balloon inflation (@ 15 atm) the balloon burst.There was a gradual drop in pressure.The device was not moved or re-positioned in the lesion prior to the burst.Excessive force was not used during delivery.It was reported that the physician encountered difficulty removing the device following the burst.Physician completed the procedure.Patient's status is excellent post procedure, no complications.

Manufacturer Narrative

Additional information received: the euphora balloon passed through a previously deployed stent and was placed in the 1st diagonal and inflated for 20 seconds.The physician has confirmed that this was a difficult procedure in trying to retrieve the detached parts however was able to retrieve the detached parts back into the guide catheter without the use of a snare.Patient is doing well.The physician confirmed that parts were removed, pulling a bit higher than usual, then did an angiographic control and saw nothing left in the patient.However there is some risk.Cine image review update: the cine images capture the deployment of the stent and delivery of a balloon device through the stent cell.The images show the poba balloon inflated with no evidence of a burst.The images do not appear to capture the delivery, inflation, burst and subsequent material detachment.

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: 5797686
• MDR Text Key: 49625079
• Report Number: 9612164-2016-00682
• 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
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Catalogue Number: EUP27510X
• Device Lot Number: 210969216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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 Age: 78 YR
• Patient Weight: 100