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

Model Number	EUP3530X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
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
A euphora rx balloon was intended to be used during a procedure to treat a lesion in the mid rca, exhibiting moderate tortuosity and moderate calcification.Stenosis was 90%.There was no damage noted to packaging, and the device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was not pre-dilated.The device did pass through a previously deployed stent.Resistance was encountered when advancing the device and excessive force was not used during delivery.It is reported that balloon deflation difficulties occurred - the balloon would not deflate at the lesion site.The physician removed the device while inflated, after multiple attempts to deflate.No patient injury reported.
Additional Manufacturer Narrative
Device evaluation summary: device returned for evaluation.The device returned with the balloon folds had been expanded.Crystallised contrast was visible in the balloon.The proximal balloon bond was necked.It was not possible to inflate the device due to deformation of the proximal balloon bond.Therefore, it was no possible to preform deflation testing.It was not possible to verify the inner lumen patency due to deformation of the proximal balloon bond.No deformation was evident to the distal tip.No other damage was evident to the remainder of the device.Additional information: deflation difficulties were noted on the first inflation; 14 atm of inflation pressure was applied on the first inflation.The balloon was then inflated to 22 atm as the balloon would not deflate.It was stated that there looked like there was air in the balloon.The balloon was pulled out of the artery and into the aorta inflated.The balloon was partially deflated and removed via the groin sheath with little difficulty.The concentration of contrast/saline used was 40/60.Lot number updated.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: 10050823
• Report Number: 9612164-2020-01869
• Device Sequence Number: 16859307
• Product Code: LOX
• UDI-Device Identifier: 00643169560314
• UDI-Public: 00643169560314
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/23/2020

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: 03/25/2021
• Device Model Number: EUP3530X
• Device Catalogue Number: EUP3530X
• Device Lot Number: 217379134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1