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

Model Number EUP3520X

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/05/2021

Event Type  Injury  

Event Description

A euphora rx balloon catheter was attempted to be used to treat the distal left popliteal artery.It was stated that there was stenotic vasculature through the left peripheral vasculature.The device was inspected prior to use with no issues noted.Negative prep was performed with no issues noted.The lesion was not pre-dilated.The device did pass through a previously deployed stent.It was reported that upon delivery of the balloon to the popliteal artery and during positioning of the device, the balloon sheared off the catheter shaft.The shaft was removed successfully the balloon portion was trapped against the popliteal vessel wall using a self-expanding stent, without apparent obstruction of blood flow across the vessel.No further patient injury reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Add an annex d code 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12802452
• MDR Text Key: 280689850
• Report Number: 9612164-2021-04383
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169560291
• UDI-Public: 00643169560291
• 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
• Report Date: 01/27/2022

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 Expiration Date: 02/05/2022
• Device Model Number: EUP3520X
• Device Catalogue Number: EUP3520X
• Device Lot Number: 219452593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 01/27/2022
• Date Device Manufactured: 02/06/2020
• 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 Sex: Male