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

Catalog Number	EUP2010X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician intended to use a euphora balloon catheter in a lesion in the proximal lad, severe calcification, severe tortuosity and 70 % stenosis.There was no damage noted to packaging, no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was pre-dilated.The euphora balloon did pass through a previously deployed old stent in the lad.No resistance was encountered when advancing the device.During removal of the device it is reported that balloon detached.A stent was used to jail the detached portion against the vessel wall.The device was not kinked and re-straightened during use.
Additional Manufacturer Narrative
The device was returned for analysis.The device returned with a detachment of balloon material, approximately 23.3cm distal to the guidewire entry port bond.The balloon material was jagged and uneven at the detachment site.The inner shaft proximal to the detachment site was stretched and bunched.Only one inner shaft marker was present on the inner shaft.Stretching was evident to the distal tip and distal tip bond.The most distal part of the tip was torn.Blood was visible in the inner lumen of the device.Bunching was evident along the distal shaft.Damage was evident to the guidewire entry port.The hypotube was kinked in numerous places.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: 6502893
• Report Number: 9612164-2017-00457
• Device Sequence Number: 11235
• Product Code: LOX
• UDI-Device Identifier: 00643169559875
• UDI-Public: 00643169559875
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 06/29/2017

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: 11/25/2018
• Device Catalogue Number: EUP2010X
• Device Lot Number: 212373226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 06/29/2017; 06/29/2017
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 07/25/2017; 10/02/2017
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 60