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

Catalog Number	EUP2515X
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
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 the procedure, an euphora ptca balloon catheter was used to treat a mildly tortuous and moderately calcified lesion located in the mid left anterior descending artery, exhibiting 100% stenosis.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that inflation difficulties were encountered during balloon inflation.It was described that there was no inflation but then a sudden abrupt inflation occurred.Balloon deflation difficulties were also noted at the lesion site, where by it was described as a not smooth balloon deflation difficulties and the balloon did not deflate at the lesion site.It was also informed that there was also a difficulty removing device prior to stent deployment.There were multiple attempts to deflate the balloon.Retraction was attempted to the mouth of the catheter to get the device back into the guide.Patient status post-procedure is alive with no injury.
Additional Manufacturer Narrative
Additional information: no difficulties were noted when removing the protective sheath and stylette of the euphora balloon.The euphora was removed.A stent was implanted and was post-dilated with another balloon.The procedure was completed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the balloon returned with no blood visible in the balloon and inflation lumen.The balloon returned partially inflated with balloon folds expanded.The distal shaft immediately proximal to the proximal marker band appeared stretched and kinked.Stretching was evident to the balloon bond.It was not possible to inflate the device.The guidewire lumen patency could not be verified with a 0.015 inch mandrel.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7410568
• Report Number: 9612164-2018-00669
• Device Sequence Number: 19073272
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/04/2018

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: 11/23/2019
• Device Catalogue Number: EUP2515X
• Device Lot Number: 214453032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2018
• Initial Date Received by Manufacturer: 03/15/2018
• Supplement Date Received by Manufacturer: 04/18/2018; 06/29/2018; 08/08/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/16/2018; 07/27/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1