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

Model Number	NCSP27512X
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving one nc sprinter balloon catheter there were balloon deflation difficulties, and the device would not deflate at the lesion site following the first inflation.The device was inspected prior to use and negative prep aration was performed with no issues.The device did pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The balloon was slowly moved out of the patient.No patient complications have been reported as a result of this event.
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.
Additional Manufacturer Narrative
Image analysis: one still image received for analysis.Image depicts an inflated balloon outside of the body.A secondary inflation is evident on the distal shaft proximal to the balloon.Image confirms the reported deflation difficulty.Additional information: the balloon failed to deflate.A pressure of 12 atm was applied for the inflation and no difficulties were noted during inflation of the device.The device was not moved or repositioned while inflated.It was not difficult to remove the protective sheath.It was not difficult to remove the packaging stylette.A little bit difficulty was experienced when removing the balloon from the lesion.Name and phone number of the initial reporter 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
Additional information: initial reporter's full name.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
Additional information: annex d code.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 SPRINTER 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: 21761454
• Report Number: 9612164-2025-01707
• Device Sequence Number: 21005645
• Product Code: LOX
• UDI-Device Identifier: 00643169282360
• UDI-Public: 00643169282360
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: P790017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/05/2025

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: 07/25/2026
• Device Model Number: NCSP27512X
• Device Catalogue Number: NCSP27512X
• Device Lot Number: 229333934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 04/09/2025; 05/23/2025; 06/04/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/01/2025; 05/29/2025; 06/05/2025
• Date Device Manufactured: 07/25/2024
• 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