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

Model Number EUP2530X

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/20/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure prompted by mi, an attempt was made to use one euphora balloon catheter to treat a non tortuous and non calcified lesion in the lcx artery with 85% stenosis.There was no damage noted to the device packaging.There were no issues noted removing the device from the protective hoop.The device was not inspected.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 lesion was pre-dilated twice using a non medtronic balloon.A dissection occurred after inflation of the non medtronic balloon.The euphora balloon was selected to treat the dissection.It was reported that during prep of the euphora, the protective sheath on the balloon was not removed.The balloon was advanced to the lesion and inflation was performed.Inflation was performed with 2atm but the balloon did not inflate, inflation pressure was raised to 4atm and 6atm and the lesion was expanded.Foreign material was confirmed when the final confirmation was performed with intravascular ultrasound (ivus).Optical coherence tomography (oct) confirmed that it was a protective sheath.The proximal side of the protective device was grabbed with a snare and removed from the patient.The patient is alive with no injury reported.

Manufacturer Narrative

Product analysis: the sheath was connected to a snare.The euphora device was not received for analysis.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

Correction: device evaluation summary updated: sheath and snare were returned for evaluation.The sheath was connected to a snare.The sheath was intact, no portion of the sheath was missing.The euphora device was not received for analysis.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: 12224597
• MDR Text Key: 263377031
• Report Number: 9612164-2021-02878
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2021

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: 04/01/2023
• Device Model Number: EUP2530X
• Device Catalogue Number: EUP2530X
• Device Lot Number: 222007617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 07/26/2021
• Supplement Dates Manufacturer Received: 09/30/2021; 10/29/2021
• Supplement Dates FDA Received: 10/13/2021; 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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