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

Catalog Number	EUP1515X
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the guidewire did not return with the device.The device returned with kinks evident along the hypotube.The transition tubing was pinched approx.4.6cm and 6cm distal to the transition bond.The inner shaft was bunched immediately distal to the proximal balloon bond and both proximal and distal to the inner shaft marker band.Deformation was evident to the distal tip.Resistance was noted when loading a 0.014 inch guidewire and 0.015 inch mandrel due to the damage on the inner shaft.Future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a euphoria rx balloon to treat a tight calcified lesion located in the mid left anterior descending (lad) artery which was reported to be mildly calcified but not tortuous with 85% stenosis.No damage was noted to packaging and no issues were noted when removing the device from the tray/hoop.The device was inspected with no issues identified.Negative prep was also performed with no issues.It was reported that the balloon was being used to help the non-mdt brand wire cross the lesion.The guidewire was examined and flushed before use with no issues noted.No issues noted loading the balloon on the guidewire.Resistance was noted when trying to move the balloon along the non-mdt wire.The balloon then got stuck on the wire during delivery of the guidewire to / across the lesion site.Dissection was noted but it is unconfirmed if this was due to the balloon or not.The lesion was stented and the patient is reported to be 'fine'.The device did not pass through a previously-deployed stent and excessive force was not used during delivery.Difficulties were reported while attempting to remove the balloon and the balloon could not be removed by itself.The wire and balloon were removed together.No other devices were used with the non-mdt wire involved in this event.
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: 6636011
• Report Number: 9612164-2017-00752
• Device Sequence Number: 16276231
• Product Code: LOX
• UDI-Device Identifier: 00643169559844
• UDI-Public: 00643169559844
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/16/2017

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: 01/17/2019
• Device Catalogue Number: EUP1515X
• Device Lot Number: 212621123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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