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

Model Number	EUP2512X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/09/2020
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
A euphora rx ptca balloon catheter was attempted to be used to treat a mildly tortuous, moderately calcified lesion with 95% stenosis in the om artery.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was not 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.It was reported that the balloon would not deflate at the lesion site.It was stated that attempts were made using several indeflators but to no avail.Saline was then injected in the balloon and inflated.The device then deflated after 10 more minutes.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Product analysis summary: the device was returned with the balloon folds expanded.Crystalized contrast was evident in the balloon.Deformation was evident to the proximal balloon bond.The balloon was inflated to nominal pressure of 8 atm and maintained pressure.The proximal balloon bond inflated as a resulted of deformation.The balloon deflated with no issues noted.No other damage was evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: no difficulties experienced when removing the protective sheath.It was reported that no difficulties were noted when inflating the device.The device was not moved or repositioned prior to the deflation difficulties.Deflation difficulties occurred after the first inflation.50/50 contrast/ saline was used.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: 9609621
• Report Number: 9612164-2020-00342
• Device Sequence Number: 2669360
• Product Code: LOX
• UDI-Device Identifier: 00643169560017
• UDI-Public: 00643169560017
• 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,Followup
• Report Date (Section B): 03/11/2020

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: 07/05/2021
• Device Model Number: EUP2512X
• Device Catalogue Number: EUP2512X
• Device Lot Number: 218038134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/22/2020; 02/19/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/13/2020; 03/11/2020
• 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: Other; Required Intervention
• Patient Age: 64 YR