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

Catalog Number	EUP3020X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 lesion.The device was inspected with no issues.Negative prep was performed with no issues.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that a balloon burst occurred on the first inflation.It is indicated that the balloon ruptured circumferentially.The patient is reported to be alive with no injury.
Additional Manufacturer Narrative
The euphora rx ptca balloon catheter was intended to pre-dilate the lesion.The procedure was completed and there was no harm to the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: there was a radial burst of the balloon material.The device returned with contrast and blood visible in the balloon and inflation lumen.The distal portion was bunched and had folded up on the distal tip.While anchoring the distal tip it was possible to pull the distal balloon material proximally.The balloon material was jagged and uneven on both sides of the burst site.Deformation was evident to the inner member 0.4cm and 0.8cm proximal to the distal tip.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
• 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: 8128110
• Report Number: 9612164-2018-03460
• Device Sequence Number: 16515722
• Product Code: LOX
• UDI-Device Identifier: 00643169560161
• UDI-Public: 00643169560161
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/06/2019

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: 09/20/2019
• Device Catalogue Number: EUP3020X
• Device Lot Number: 214053777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 02/04/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/10/2019; 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1