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

Model Number NCEUP32515X

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2024

Event Type  Injury  

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.

Event Description

An attempt was made to use one 3.25x15mm nc euphora balloon catheter to treat a non-tortuous, non-calcified lesion with 70% stenosis in the mid right coronary artery (rca).The device was not inspected.Negative prep was performed with no issues noted.The lesion was pre-dilated with a 2.5x15mm euphora balloon catheter without complications.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.It was reported that inflation difficulties were encountered during balloon inflation.It was noted that the balloon inflated slower than expected at 12atm.Following the first inflation, the balloon would not deflate at the lesion site. a new indeflator was opened however, the balloon would not deflate.The indeflator was removed and it was attempted to draw back using a 12cc syringe however, the balloon did not deflate.It was detailed that the inflated balloon was then manually pulled proximally towards the ostium and into the aorta outside the guide.An attempt was made to puncture the balloon using a non-medtronic wire but it did not puncture.The balloon was inflated to 26atm for a forced rupture and balloon was removed from the patient.The nc euphora balloon catheter was being used to size the diameter before stent implantation.It was stated that stent delivery to the mid rca was smooth without resistance or tortuosity.The patient is alive with no further injury.

Manufacturer Narrative

Product analysis: the device returned with a non-medtronic inflation device, a non-medtronic guidewire and a non-medtronic guide catheter.Kinks were evident on the hypotube.The forced burst during procedure by the physician was evident on the inflation lumen proximal to the proximal balloon bond.The balloon folds returned expanded.Blood was visible in the balloon.No deformation was evident to the distal tip.Inflation/deflation could not be carried out to the condition of the lumen.No other damage evident to the remainder of the device.Additional information: it was not difficult to remove the protective sheath.It was not difficult to remove the packaging stylette.A concentration of isovue 370 - 50% contrast/50% heparinized saline was used during the procedure.The balloon failed to deflate.A non medtronic guide was used in the procedure.The nc euphora was moved or repositioned while inflated when it was pulled back once it wouldn't deflate.The inflation devices used during the procedure were non medtronic devices.The same inflation device was successfully used with other devices, as the lesion was pre-dilated with a smaller balloon using the same inflation device.There was no injury to the patient as a result of the event.Initial reporter phone number 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: annex d code added.Product analysis correction: the proximal bond may have been necked but due to the condition of the returned device, this could not be confirmed during 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: NC 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: 18619166
• MDR Text Key: 334256826
• Report Number: 9612164-2024-00545
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169395794
• UDI-Public: 00643169395794
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141090
• 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: 03/13/2024

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: NCEUP32515X
• Device Catalogue Number: NCEUP32515X
• Device Lot Number: 227104023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 02/19/2024; 03/11/2024
• Supplement Dates FDA Received: 02/29/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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: 65 YR
• Patient Sex: Male