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

Catalog Number EUP2010X

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An attempt was made to use a euphora rx balloon for pre-dilation treatment of a moderately calcified lad lesion.No damage was noted to device packaging.There were no issues removing the device from the hoop.The device was inspected prior to use and negative prep was performed.There were no issues when removing the stylet and protective sheath.Resistance was noted in the initial stage when the non-medtronic guidewire was passed through the tip portion of the balloon.Inflation difficulties were reported as the balloon could only partially inflate at nominal pressure.It was not possible to deflate the balloon at the lesion site.It was reported that it was difficult to remove the device from the patient due to the device being partially inflated.Intervention was attempted to deflate the partially inflated balloon but it was difficult.The balloon was removed, and the procedure was completed using a non-medtronic product.The patient had no problem post procedure and no patient injury was reported.

Manufacturer Narrative

Additional information: the device did not pass through a previously deployed stent.Small to medium tortuosity reported slight resistance reported product analysis summary: the device returned with balloon inflated.Contrast was visible in the balloon and inflation lumen.Deformation was evident to the distal tip.Stretching was evident to the balloon bond.The device passed negative prep.It was not possible to inflate or deflate the balloon due to stretching of the balloon bond.No other damage was evident to the remainder of the device.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: 8207932
• MDR Text Key: 131773839
• Report Number: 9612164-2019-00006
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Catalogue Number: EUP2010X
• Device Lot Number: 213556116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Date Device Manufactured: 07/05/2017
• 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