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

Model Number	NCEUP2527X
Medical Device Problem Codes	Burst Container or Vessel (1074); Inflation Problem (1310); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An attempt was made to use one nc euphora rx balloon catheter to treat a mildly tortuous and mildly calcified lesion located in the mid left anterior descending (lad) artery.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was not pre-dilated, the device was being used to pre-dilate the lesion.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.It was reported that inflation difficulties were encountered during balloon inflation at 12 atm.It was stated that the device did not inflate properly under fluoro.There was partial inflation of the balloon.The device was removed and tested, where it was noticed that the balloon was inflating proximal to the balloon portion of the catheter.The device was not moved or repositioned while inflated.The same inflation was device successfully used with other devices.The patient is alive with no injury.
Additional Manufacturer Narrative
Product analysis: the device was returned for analysis.The device returned with a complete radial burst of the inflation lumen at the proximal bond, exposing the inner member.It appeared that the balloon bond expanded leading to the burst.The inflation lumen material was jagged and uneven at the burst site.The detached lumen material did not return for analysis.Inflation testing could not be performed due to the condition of the device.The balloon returned deflated.No deformation evident to the distal tip.No other damage evident to the remainder of the device.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: NC EUPHORA RX
• Common Device Name: 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: 19369520
• Report Number: 9612164-2024-02455
• Device Sequence Number: 15384552
• Product Code: LOX
• UDI-Device Identifier: 00643169396135
• UDI-Public: 00643169396135
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2025
• Device Model Number: NCEUP2527X
• Device Catalogue Number: NCEUP2527X
• Device Lot Number: 227622701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown