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

Catalog Number	EUP3012X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2019
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
An attempt was made to use a euphora rx balloon catheter to treat a lesion in the proximal ramus.The lesion exhibited mild tortuosity and mild calcification.No difficulties were noted when removing the protective sheath or packaging stylette from the device.The device was inspected, and negative prep was performed prior to use with no issues noted.The lesion was pre-dilated.During the procedure a second wire was used to protect the lad.The euphora was then passed to the lesion with ease.The device did not pass through a previously deployed stent and resistance was not encountered when advancing the device.A 50/50 concentration of contrast / saline was used.When an attempt was made to inflate the balloon, the physician could not see the balloon, it was assumed that the euphora device was not prepped properly, however the nurse reported that there was sufficient contrast available.When an attempt was made to deflate, it was felt that the balloon was still inflated as resistance was felt.Deflation difficulties noted after the first inflation.Contrast was injected to see the balloon was still inflated.Negative was pulled on the inflation device.A syringe was connected to the balloon pulling negative on it.Nothing would work.The entire system was then retracted into the guide and started all over.No patient injury, pci was successful.
Additional Manufacturer Narrative
Product analysis summary: the device was loaded into the guide catheter with the y connector attached.The distal end of the device was visible coming out of the guide catheter.The balloon appeared to be inflated.It was not possible to remove the device from the guide catheter.The device and guide catheter with y connector were placed in the bath to aid the removal of the device.On removal from the bath the device was removed from the guide catheter with no issues noted.The balloon was deflated on removal.Blood was visible in the balloon.Deformation was evident to the distal tip.Stretching was evident to the proximal balloon bond and the inner member.Stretching was evident to the distal shaft.Severe deformation was evident to the transitional tubing material.It was not possible to inflate the balloon to perform deflation testing due to the condition of the returned device.No other damage was evident to the remainder of the device.Image review: the images capture a lesion site in the proximal ramus.A support guidewire is evident in the lad.The delivery and first inflation of a balloon device is evident.The contrast indicates the balloon is only inflated as far as the distal marker band, as the contrast does not exceed past the distal marker band.This could suggest air is present in the balloon, or potential inflation difficulties were encountered.This however cannot be confirmed.The images then show the delivery and second inflation of a balloon device.The contrast indicates the balloon is only partially inflated halfway between the proximal and distal marker bands, which could potentially indicate inflation difficulties.The images then capture the delivery and third inflation of a balloon device.Again, the contrast indicates the balloon is only inflated up to the distal marker band, suggesting air could be present in the balloon or potential inflation difficulties were encountered.It cannot be confirmed from the images which inflation corresponds to the euphora 3.0x12mm balloon device.The deflation difficulties reported by the account cannot be confirmed from the images.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: 8304065
• Report Number: 9612164-2019-00411
• Device Sequence Number: 13779047
• Product Code: LOX
• UDI-Device Identifier: 00643169560147
• UDI-Public: 00643169560147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/30/2019

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: 04/02/2020
• Device Catalogue Number: EUP3012X
• Device Lot Number: 215187113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1