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

Model Number	EUP3015X
Medical Device Problem Codes	Burst Container or Vessel (1074); Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure a euphora rx ptca balloon catheter was used to pre-dilate a mildly tortuous and calcified lesion exhibiting 90% stenosis located in the mid left anterior descending artery (lad).The device was inspected with no issues noted.Negative prep was performed without issue.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.It was reported that the device would not deflate at the lesion site and was therefore pulled into the aorta and popped.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: no issues noted when removing the sheath / packaging stylet.The balloon inflated without issue to 14 atm incident occurred on the first inflation the physician used the inflation device to raise the atmospheres up and down until balloon popped.It was noted that when they first went to inflate the balloon the pressure went up on the inflation device but they could visually not see the balloon going up on fluoro.Initially they thought there was no contrast in the balloon and no issue.When they lowered the inflation device they tried to re-prep the balloon with contrast.They went up with the balloon saw contrast and could not get the balloon down.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: the balloon folds were expanded.Blood was visible in the balloon and inflation lumen.Slight deformation was evident to the distal tip.The proximal balloon bond appears to have inflated and then burst.The material at the burst site was uneven.It was not possible to inflate the balloon in order to perform deflation testing, due to the condition of the returned device.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.

• 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: 8815045
• Report Number: 9612164-2019-02993
• Device Sequence Number: 3258494
• Product Code: LOX
• UDI-Device Identifier: 00643169560154
• UDI-Public: 00643169560154
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 11/06/2019

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: 03/21/2021
• Device Model Number: EUP3015X
• Device Catalogue Number: EUP3015X
• Device Lot Number: 217371291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 07/23/2019; 09/16/2019; 11/04/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/19/2019; 10/14/2019; 11/06/2019
• 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