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

Catalog Number EUP2515X

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the procedure, an attempt was made to use one euphora rx ptca balloon catheter to treat a lesion located in the distal mammary graft.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that a balloon detachment occurred during removal of the device from the patient.It was stated that an attempt to snare the detached balloon segment that was located approximately in the aorta just distal to the renal arteries without success.It was stated that the euphora balloon was advanced on a non-medtronic wire 300cm per femoral approach that appeared to have a severe kink in the wire.The guide catheter was removed before attempting to advance the euphora balloon.On attempting to advance the balloon, it could not pass the wire kink and when trying to remove the balloon it required significant force given that the wire was conformed to the wire kink.When the balloon was released from the kink and removed from the patient, it was observed the balloon portion of the catheter detached.The patient was reported to be alive with no further injury.

Manufacturer Narrative

Additional information: it was stated that two resolute onyx des (ronyx30015ux and ronyx30008ux) were successfully implanted in the lima during the procedure.Device lot number received correction: patient code - c62946 it was indicated that the detached portion of the balloon remains in the patient.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.

Manufacturer Narrative

Product analysis summary: the device returned with a detachment at the distal shaft, immediately distal to the exchange joint.The core wire was exposed.The detached section did not return for analysis.The material at the detachment site was stretched and uneven.The exchange joint was stretched and torn.There was no other damage evident to the remainder of the device.Image analysis: the euphora was advanced over a guide-wire into tortuous anatomy, the reported detachment was not captured in the images returned.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, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10199337
• MDR Text Key: 198701141
• Report Number: 9612164-2020-02329
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K143480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2022
• Device Catalogue Number: EUP2515X
• Device Lot Number: 219395751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 82