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

Catalog Number EUP3015X

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A euphora balloon catheter was intended to be used to treat a lesion.The device was inspected before use with no issues noted.Negative prep/purging was performed on the device prior to use with no issues noted.It is reported that during the inflation of a euphora balloon catheter, the doctor realized that the balloon inflated partially, but was not inflating fully.The physician thought there was a hole, so they removed it from the patient's body.When it was removed he inflated it and confirmed that there was a hole.It is not known if the hole was present prior to use, from prepping or from insertion.The procedure was completed with a new 3.0x15mm euphora.No patient injury is reported.

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: 7713275
• MDR Text Key: 114948182
• Report Number: 9612164-2018-01830
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169560154
• UDI-Public: 00643169560154
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2020
• Device Catalogue Number: EUP3015X
• Device Lot Number: 214781651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 11/09/2018
• Supplement Dates FDA Received: 10/03/2018; 11/13/2018
• Date Device Manufactured: 01/25/2018
• 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: 60 YR