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

Catalog Number	EUP2515X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the device returned with a stopcock and syringe attached to the luer.Numerous kinks were visible along the hypotube.The distal shaft was kinked 6.9 cm and 13 cm distal to the guidewire entry port.The balloon material was torn in a radial pattern.Approximately 8 mm of balloon material remained distal to the proximal balloon bond.The inner shaft was stretched, kinked and bunched.The balloon material distal to the tear site was pulled distally on the distal tip and bunched.The balloon material was torn, jagged and uneven on both sides of the tear site.The inner shaft markers had moved proximally on the inner shaft.The tip bond was stretched.There was slight deformation to the distal tip.There was no detachment of material on the device.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
The physician intended to use a sc euphora balloon catheter to pre-dilate a severely calcified target lesion with sharp plaque.No damage was noted to the packaging and no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep performed with no issues reported.The lesion was pre-dilated.It was reported that during the first balloon inflation, the balloon ruptured and that there was a sudden drop in pressure noted on the inflation device.Following this, balloon removal difficulties were encountered.When the balloon was removed as normal over the wire, it was bunched up toward the tip of the device.It is reported that the same inflation device was used for all inflations pre and post.There is no planned extra procedure at this time.At the end of the case the patient was fine and was stable.

• 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: 6427304
• Report Number: 9612164-2017-00316
• Device Sequence Number: 38209
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 03/23/2017

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: 12/05/2018
• Device Catalogue Number: EUP2515X
• Device Lot Number: 212411852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 04/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1