MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV NC SPRINTER RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,

Model Number	NCSP3012X
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
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
It was reported that during a procedure involving one nc sprinter rx coronary balloon catheter, balloon deflation difficulties were encountered and the balloon would not deflate at the lesion site.It was believed that the device took a little extra effort to remove through the guide catheter.The device was inspected prior to use and negative prep was performed with no issues noted.The device passed through a previously-deployed stent.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: there were no difficulties noted during inflation of the device.It was later detailed that initially the balloon failed to deflate and then after some time it was able to deflate which was unusual.There was a slight resistance experienced to remove the balloon.It was not difficult to remove the protective sheath/stylette.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
Product analysis: the device was returned for evaluation.The device was returned with the balloon in a post-inflated state.The balloon was loaded through a sheath.An indeflator with pressure gauge was used to inflate the balloon to its nominal pressure of 10atms and its rated burst pressure (rbp) of 18atms.The balloon was then deflated in approximately 11 seconds without difficulty.The balloon was then removed from the sheath without issue.Correction: it was stated that deflation time was a few minutes.Annex a codes a150208 and a150207 were removed.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 S. DE R.L. DE CV; av. paseo cucapah 10510 el lag; tijuana baja california,mx 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo cucapah 10510 el lag; tijuana baja california,mx 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23066540
• Report Number: 9617601-2025-01466
• Device Sequence Number: 10044861
• Product Code: LOX
• UDI-Device Identifier: 00643169282414
• UDI-Public: (01)00643169282414(17)261029(10)229963423
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2025

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 Model Number: NCSP3012X
• Device Catalogue Number: NCSP3012X
• Device Lot Number: 229963423
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 11/19/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/06/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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