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

Catalog Number	EUP3015X
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EUPHORA RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 7713275
• Report Number: 9612164-2018-01830
• Device Sequence Number: 1107254
• Product Code: LOX
• UDI-Device Identifier: 00643169560154
• UDI-Public: 00643169560154
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2020
• Device Catalogue Number: EUP3015X
• Device Lot Number: 214781651
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 11/09/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR