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

Catalog Number	EUP1520X
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the distal tip was stretched.A section of the balloon bond and distal outer shaft were stretched and had expanded on inflation of balloon.The device was placed in the water bath to disperse the residue in the inflation lumen in order to aid inflation.The device passed negative prep.The device was inflated to 8atm and maintained pressure with no leak present.Section of inflation lumen inflated proximal to the balloon bond.The inner lumen patency was verified with a 0.015 inch mandrel.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
As reported, the physician intended to use an eurphora rx balloon to treat pda with minimal calcification, 90% stenosis.No damage was noted to packaging nor were there any issues noted when removing the device from the hoop/tray.The device was inspected with no issues and negative prep was performed with no issues.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device so no excessive force was applied.There was no sudden or gradual drop in pressure noted on the inflation device.The device was not moved or re-positioned prior to the issue.It was reported that during balloon inflation at 14 atm, distal to the balloon, there was a 3mm bubble.Staining was seen where the bubble was on the balloon.The balloon didn't burst.On the second inflation it inflated only at the distal end and looked like a guardwire.Dissection occurred.Physician feels the dissection was caused by the balloon the procedure was completed using a non medtronic device.

• 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: 6685536
• Report Number: 9612164-2017-00844
• Device Sequence Number: 137620
• Product Code: LOX
• UDI-Device Identifier: 00643169559851
• UDI-Public: 00643169559851
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2019
• Device Catalogue Number: EUP1520X
• Device Lot Number: 212990783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 50 YR