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

Model Number	EUP3020X
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
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
During a procedure a euphora rx ptca balloon catheter was used to treat a non tortuous, non calcified lesion exhibiting 85% stenosis located in the distal right coronary artery (rca).The device was inspected with no issues noted.Negative prep was performed without issues.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered and excessive force was not used during delivery.It was reported that inflation difficulties were encountered.The balloon was inflated to 8 atms for 30 seconds and the balloon failed to fully inflate following the first inflation.It was also reported that deflation issues were also encountered with the partially inflated balloon being unable to deflate upon negative pressure being applied.The balloon was removed from the lesion site partially inflated and removed from patient intact through a medtronic guide catheter.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
Product analysis summary: the guidewire was loaded in the device, it was not possible to remove the guidewire.The distal tip and the balloon material appeared to have folded in on itself.The distal shaft material was stretched resulting in the balloon not positioned correctly over the marker bands.The proximal balloon bond was stretched.The distal shaft was stretched.The exchange joint was torn.The transition shaft was stretched, torn and kinked.It was not possible to perform inflation and deflation testing due to the condition of the returned device.There was no other damage evident to the remainder of the device.An image provided shows a balloon positioned in a vessel.The balloon appears to have been partially inflated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: it was not difficult to remove the protective sheath and packaging stylette.The balloon was not moved or repositioned in the lesion while inflated.Removal difficulties were reported.The balloon would not deflate after 10 seconds.The balloon would not pull through the 6fr.Launcher guide catheter.The balloon, the.014 wire and the guide catheter were removed as one unit out of the patient.50% contrast / 50% 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: 9646023
• Report Number: 9612164-2020-00470
• Device Sequence Number: 2767888
• Product Code: LOX
• UDI-Device Identifier: 00643169560161
• UDI-Public: 00643169560161
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/15/2020

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: 09/19/2021
• Device Model Number: EUP3020X
• Device Catalogue Number: EUP3020X
• Device Lot Number: 218537232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 02/03/2020; 04/01/2020; 04/14/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/25/2020; 04/08/2020; 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR