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

Model Number	NCEUP3027X
Medical Device Problem Codes	Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: three still procedural images were provided for analysis.Images depict a balloon being used to post-dilate a deployed stent in the right coronary artery (rca).Contrast is visible in the balloon proximal to the proximal markerband, indicating deformation to the balloon material and inflation of the proximal balloon bond.Additional information: the balloon was being used to post dilate a deployed stent.The device was not moved or repositioned while inflated.There was no deflation difficulties.It was not difficult to remove the balloon from the patient.The same inflation device was successfully used with other devices.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.
Additional Manufacturer Narrative
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.
Event or Problem Description
An attempt was made to use one nc euphora coronary balloon catheter to treat a non-tortuous, non-calcified lesion located with 70% stenosis in the mid right coronary artery (rca).The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated.The device did 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.The balloon was initially used, inflated to nominal pressure, and then removed to perform intravascular ultrasound (ivus).Then the balloon was re-inserted and inflated to 25 atm, and after the third inflation the balloon started growing proximally beyond the proximal marker.The patient is alive with no injury.
Additional Manufacturer Narrative
Product analysis: the device was returned for analysis.The device returned with balloon folds expanded.Crystallized contrast was present in balloon.Kinks were evident to the hypo-tube.There was no evidence of necking on the proximal balloon bond.Deformation was evident to the distal tip.The balloon passed negative prep.The balloon was inflated to 12 atm (nominal pressure) and maintained pressure with no evidence of deformation to the proximal balloon.The balloon was subsequently inflated to 20 atm (rated burst pressure) and slight material deformation was evident to the proximal balloon bond.No other deformation was 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: 20651750
• Report Number: 9612164-2024-05197
• Device Sequence Number: 6696954
• Product Code: LOX
• UDI-Device Identifier: 00643169395831
• UDI-Public: 00643169395831
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup,Followup
• Report Date (Section B): 12/11/2024

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: 07/10/2026
• Device Model Number: NCEUP3027X
• Device Catalogue Number: NCEUP3027X
• Device Lot Number: 229224501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 11/11/2024; 12/02/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 11/13/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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