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

Model Number	EUP2515X
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	09/07/2020
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
A euphora rx ptca balloon catheter was used during a procedure to treat a lesion.There was no issues noted when removing the device from the hoop.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre dilated.The device did not pass though a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.During the vessel prep the balloon went to the legion site, the inflation device was used to inflate the balloon.It appeared that there was no contrast in the balloon and they were unable to see if the balloon up or down.The balloon was then prepped again.Then they used the inflation device to inflate the balloon to 14 atm.It was reported that when they wanted to bring the balloon down the balloon would not deflate.They tried to raise the inflation and lower the inflation and had no success and bring it a balloon down.Fortunately the vessel was large enough that they were able to withdraw the balloon the wire and the guide.With no significant damage to the vessel.They went ahead and stented the vessel and said that there is no patient related problems.
Additional Manufacturer Narrative
Product analysis summary: numerous kinks were evident to the hypotube.Deformation was evident to the exchange joint.The balloon folds were partially expanded.Hardened contrast and blood were visible in the inflation lumen and balloon.Necking was evident to the balloon bond.It was not possible to perform inflation/deflation testing due to the necking.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood/deformation in the guidewire lumen.No other deformation was noted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the device was being used to treat a lesion exhibiting 99% stenosis in the mid-lad.There were no difficulties noted when removing the protective sheath or the packaging stylette from the device.The inflation device was disconnected and the balloon was then prepped again.A 50/50 concentration of contrast / saline was used.It was stated that one inflation was performed prior to experiencing the deflation difficulties.The device was not moved or re-positioned in the lesion.It was stated that there was difficulty experienced getting the balloon out of the vessel but fortunately the vessel was large enough that they were able to withdraw the balloon the wire and the guide with no significant damage to the vessel.The patient is alive with no reported injuries.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 10507504
• Report Number: 9612164-2020-03406
• Device Sequence Number: 11521318
• Product Code: LOX
• UDI-Device Identifier: 00643169560024
• UDI-Public: 00643169560024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/22/2020

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: 01/07/2022
• Device Model Number: EUP2515X
• Device Catalogue Number: EUP2515X
• Device Lot Number: 219236808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 09/14/2020; 10/07/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/01/2020; 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1