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

Model Number EUP2530X

Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 05/15/2023

Event Type  Injury  

Event Description

An attempt was made to use one euphora rx ptca balloon catheter to treat a mildly tortuous, severely calcified lesion with 95% stenosis located in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.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.The device was not kinked and re-straightened during use.It was reported that a balloon burst occurred during the second inflation at 15 atm.It was detailed that part of the balloon and marker-band detached from the balloon shaft and remained in the target vessel.The detached portion of the balloon was removed using a telescope and one 1.5x15mm euphora balloon. the distal balloon marker was initially removed but it became loose after removing the telescope and fractured balloon the balloon marker was injected back into a small proximal side branch of the circum flex using a contrast injection.It was decided to leave the balloon marker in the side branch as there was no safe way to remove it from the vessel.A percutaneous coronary intervention (pci) was successfully performed to the lad. the patient remained stable and is doing well post procedure.

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.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.

Manufacturer Narrative

Additional information: the device was being used to pre-dilate the lesion.The distal balloon marker came loose from the balloon shaft when it was removed from the artery.The device was not moved or repositioned while inflated.The same inflation device was used with other devices.It was detailed that the telescope device did not cause or contribute to the marker coming loose from the balloon shaft when the device was removed from the artery.There were no issues with the telescope device.There were no issues with the 1.5 x 15mm euphora balloon.The ruptured/fractured balloon would not have been removed from the artery without the telescope and 1.5 x 15mm euphora balloon.Correction: approximately half of the detached balloon material was removed using a telescope guide extension catheter and one 1.5x15mm euphora balloon.Image analysis: four video procedural clips of the cath lab monitor were provided.Images confirm the presence of a lesion in the proximal lad.The treatment of the lesion i.E., the balloon delivery, inflation and burst were not shown on the images.The detachment during removal was not confirmed from the images.One image confirms the presence of balloon material in the vessel being removed with the support of a guide extension catheter (gec).Two subsequent images show good vessel patency post treatment, with the marker band that was reported to have been inadvertently injected back into the vasculature present in a side branch.Product analysis: the device was returned for analysis.The device returned with kinks on the hypo-tube.A complete radial burst of the balloon occurred.The proximal of the balloon was still present on the device.The material at the burst site was jagged and uneven, the distal section of the balloon was detached exposing the inner member.The distal marker band had detached but the proximal marker band was still present on the balloon.The inner member and the distal tip were stretched.The inner lumen could not be verified with a 0.015 inch mandrel due to the stretched tip.No other damage was 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.

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.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
• Type of Device: 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: 17036495
• MDR Text Key: 316278974
• Report Number: 9612164-2023-02344
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169560055
• UDI-Public: 00643169560055
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EUP2530X
• Device Catalogue Number: EUP2530X
• Device Lot Number: 225845847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 05/31/2023; 07/17/2023
• Supplement Dates FDA Received: 06/30/2023; 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male