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

Catalog Number	EUP2506X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: kinks were evident along the hypotube.The balloon returned partially inflated, with residue present inside the balloon.The proximal balloon bond was stretched and bunched.The distal tip was slightly stretched and deformed.Kinks were evident on the distal shaft 4.8 and 6.2cm distal to the guidewire entry port bond.Negative prep was performed with no issues noted.It was not possible to deflate the balloon.Image review: the images capture the lesion site in the mid lcx exhibiting 90% stenosis as reported by the account.The delivery difficulties and the deflation difficulties of the 2.5x6mm euphora balloon are not captured on the images.The images provided show the successful inflation of a balloon prior to successful delivery and deployment of the stent.Post dilatation of the newly deployed stent was completed without any issues observed on the images provided.The images fail to confirm the deflation difficulties, and provide no insight into the root cause of the deflation difficulties reported to have been encountered.
Event or Problem Description
It was reported that the physician was attempting to use a euphora rx balloon to treat a moderately calcified and tortuous mid cx lesion exhibiting 90% stenosis.No damage was noted to device packaging.No issues removing the device from the hoop.The device was inspected with issues noted.Difficulty was encountered removing the stylette from the tip.It was reported that it would only come out 2-3cm.The tech pushed the stylette back in and twisted and was able to remove the stylette.Force was required to remove it.Device was flushed in the hoop.Negative prep was not performed.The lesion was pre-dilated.During the procedure, the device did not pass through a previously deployed stent.No resistance was encountered when advancing the device and no excessive force used.There were no difficulties encountered during inflation.60 %saline/40 %contrast was used.It was reported that after the 1st inflation, the balloon failed to deflate and the physician had to pull the balloon back into the guide and out.The device was not moved or repositioned prior to the deflation difficulties.A new euphora was used to progress the case followed by stent placement.
Additional Manufacturer Narrative
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.
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: 6518169
• Report Number: 9612164-2017-00499
• Device Sequence Number: 16340755
• Product Code: LOX
• UDI-Device Identifier: 00643169559998
• UDI-Public: 00643169559998
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/20/2017

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: 02/17/2019
• Device Catalogue Number: EUP2506X
• Device Lot Number: 212814767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: 06/30/2017; 06/30/2017; 09/20/2017
• Initial Report FDA Received Date: 04/25/2017
• Supplement Report FDA Received Date: 07/25/2017; 09/07/2017; 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-3136-2017
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 102