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

Catalog Number EUP1515X

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the physician was attempting to use one euphora balloon to pre-dilate a severely tortuous and non-calcified cx / om lesion with chronic total occlusion (cto).No damage noted to device packaging and no issues were noted when removing the device from the hoop/tray.The device was inspected and negative prep preformed with no issues noted.The lesion was pre-dilated.It was reported that the device did not pass through a previously deployed stent.During the procedure, resistance was encountered when advancing the device but no excessive force used.The balloon was inflated to 8atm.On first inflation, the balloon inflated completely, but then it deflated.A gradual drop in pressure noted on the inflation device.The device was not moved or repositioned prior to the difficulties.The same inflation device successfully was used with other devices.The physician used another balloon the same size to complete the procedure.No patient injury 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: 6180266
• MDR Text Key: 62533482
• Report Number: 9612164-2016-01316
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2018
• Device Catalogue Number: EUP1515X
• Device Lot Number: 211626694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2016
• Date Device Manufactured: 07/22/2016
• 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: 64 YR