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

Catalog Number	NCEUP2520X
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); Patient Problem/Medical Problem (2688)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure an attempt was made to use a nc-euphora rx ptca balloon catheter to treat a mildly tortuous, moderately calcified lesion exhibiting 99% stenosis located in the mid obtuse marginal (om).The device was inspected with no issues noted.Negative prep was performed without issue.The lesion was pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device and excessive force was not used during delivery.The device was not kinked and re-straightened during use.It was reported that during the first balloon inflation at 12atm a balloon rupture occurred.It was also reported that a detachment occurred at the balloon during removal of the device.The detached balloon was removed from the left main but could not be retracted into the guide catheter.An attempt was made to use a 2.5x12mm euphora balloon to trap the broken balloon at the end of the guide, however it was instead pushed forward into the left main.The broken balloon was then wired past and a 1.5x12mm euphora balloon was delivered past the broken balloon.The 1.5x12mm euphora sc balloon was inflated and the broken balloon was pull ed back into the end of the guide catheter.The 1.5x12mm euphora sc was then dilated successfully trapping the broken balloon against the end of the guide catheter.The broken balloon, wires and guide catheter were then retracted back to the tip of the radial 6f n on-mdt radial sheath.The broken balloon tip was unable to be retracted into the sheath.An attempt was made to pull the balloon out with the sheath but the broken balloon tip would not come out of the wrist.It was indicated to be stuck in the arteriotomy or in the vessel.A terumo tr band was placed on the radial for successful homeostasis.Right femoral access was then obtained and the pci procedure was successfully completed using a 2.75x26mm resolute onyx stent.Subsequently, the patient was seen by vascular surgery and setup for surgical removal of the broken balloon.No further injury was reported.
Additional Manufacturer Narrative
Image review: photo 1; image is of the distal section of a device.The markerband is visible in the image.Photo 2; image is of the distal section of a device.The markerband is visible in the image.Undetermined accessory equipment can be seen to the left of the distal section of the device.Photo 3; image is of the distal section of a device.The markerband is visible in the image.Undetermined accessory equipment can be seen to the left of the distal section of the device.Photo 4; image of the procedure provided, no relevant information pertaining to the investigation can be identified.Photo 5; image is of the detached section of the balloon placed on a ruler.Photo 6; image of the procedure provided, no relevant information pertaining to the investigation can be identified.Photo 7; image is of a hoop and a delivery system.There appears to be a detachment on the distal shaft.Device evaluation summary: the proximal balloon bond, balloon and distal tip were detached from the device.Dried blood was visible in the balloon.The balloon folds were expanded.The distal shaft material immediately proximal to the proximal markerband appeared to have inflated and then burst.The material was jagged and uneven at the burst site.The inner member was detached and did not return for analysis.There was no other damage evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: a 180 non-medtronic guidewire was used during the procedure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC 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: 8615141
• Report Number: 9612164-2019-01773
• Device Sequence Number: 14026701
• Product Code: LOX
• UDI-Device Identifier: 00643169396142
• UDI-Public: 00643169396142
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• 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): 08/12/2019

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: 02/13/2021
• Device Catalogue Number: NCEUP2520X
• Device Lot Number: 217126005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 08/08/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/26/2019; 08/12/2019
• 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: 65 YR