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

Catalog Number EUP2012X

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

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The physician intended to use a euphora balloon (eup2012x) during a procedure. The lesion exhibited moderate tortuosity, severe calcification and 95% stenosis, and was situated in the ostium of the cx artery. There were no abnormalities reported in relation to anatomy. There was no damage noted to packaging. There were no issues noted when removing the device from the hoop/tray. The device was inspected with no issues. Negative prep was performed with no issues noted. The device was not kinked or restraightened during use. The lesion was pre-dilated. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used during delivery. It was reported that the balloon was inflated to 18 atms and subsequently burst on the 1st inflation. There was a sudden drop in pressure upon inflation. The balloon was not re-positioned in the lesion prior to the burst. The physician noted that the marker was still in the vessel after the balloon catheter was removed from the body. The dislodged balloon component was not retrieved from the patient, it was compressed against the arterial wall with a 3. 5x18 mm resolute integrity des. The patient is reported as alive, no injury.

• 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: 7058496
• MDR Text Key: 92901934
• Report Number: 9612164-2017-01674
• 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

• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: EUP2012X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/27/2017 Patient Sequence Number: 1