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

Model Number	EUP2512X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.
Event or Problem Description
An attempt was made to use one euphora rx ptca balloon catheter to treat a non-tortuous, mildly calcified lesion with 95% stenosis in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.The lesion was not 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 balloon deflation difficulties occurred at the lesion site.Many attempts were made to pull negative pressure with no success.The balloon was inflated in an attempt to rupture it however, this failed.The inflated balloon was successfully pulled out of the vessel into the guide catheter and removed.It was detailed that the balloon was inflated to 12 atm and a 50/50 saline/contrast mix was used.The patient is alive with no injury.
Additional Manufacturer Narrative
Additional information: annex d code.Analysis correction: it was not possible to perform negative prep due to the condition of the returned device.Correction: negative prep was performed with no issues.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
Additonal information: no difficulties were noted when removing the protective sheath or packaging stylette.The device was being used to pre-dilate the lesion.The device was not moved or repositioned while inflated.It was reported that balloon deflation difficulties occurred after the first inflation at the lesion site.The inflation pressure applied to each inflation was 14 atm.The inflated balloon was successfully pulled out of the vessel by force.The inflation pressure applied to each inflation was 14 atm.The inflated balloon was successfully pulled out of the vessel by force.There was no injury to the patient as a result of the event.Image review: one still image of the procedural fluoroscopic images showing coronary angiogram with contrast injection confirming the location of a lesion in the mid-lad.No images were provided showing the delivery of the balloon.The circled section of the vessel appears to show the inflated balloon that has reported as failing to deflate.The mechanism of inflation and failure to deflate were not showing in the images.Product analysis: the device was received for analysis.Numerous kinks were evident along the hypotube.The length of the transition shaft was stretched and kinked.Stretching was also evident to the proximal end of the distal shaft, and the core wire was kinked.The balloon was deflated on device return.The balloon material had partially pulled over the tip and was folded in on itself and crystalized contrast was visible in the balloon.The proximal balloon bond and inflation lumen was necked.The balloon passed negative prep.It was not possible to preform deflation testing due to the condition of the proximal bond and inflation lumen.No other deformation evident to the remainder of the device.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,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16910572
• Report Number: 9612164-2023-01978
• Device Sequence Number: 20695882
• Product Code: LOX
• UDI-Device Identifier: 00643169560017
• UDI-Public: 00643169560017
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2023

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: 05/24/2024
• Device Model Number: EUP2512X
• Device Catalogue Number: EUP2512X
• Device Lot Number: 224415167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 05/11/2023; 07/10/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/06/2023; 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female