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

Catalog Number	EUP2512X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
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
An attempt was made to use one euphora rx ptca balloon catheter to treat a mildly tortuous, 99% thrombotic lesion located in the mid rca.The device was inspected with no issues.Negative prep was performed with no issues.The balloon was used for pre-dilation following a thrombectomy.There was no resistance encountered when advancing the device.Excessive force was not used during delivery.It was reported that a balloon burst occurred on the first inflation to 12atm.It is indicated that there was a gradual drop in pressure after inflation was achieved.The pressure load was unable to be advanced and the requested pressure could not be maintained.It is reported that blood return through the catheter shaft was observed.The procedure was completed using a stent.The patient is reported to be alive with no injury.
Additional Manufacturer Narrative
Lesion was non-calcified/soft plaque.No other device had been deployed prior to use of the euphora rx.No inflation difficulties were noted.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: 8093929
• Report Number: 9612164-2018-03291
• Device Sequence Number: 11266569
• Product Code: LOX
• UDI-Device Identifier: 00643169560017
• UDI-Public: 00643169560017
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/30/2019

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: 08/05/2019
• Device Catalogue Number: EUP2512X
• Device Lot Number: 213776698
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 01/29/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 01/10/2019; 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 82