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

Model Number	NCSP37515X
Medical Device Problem Codes	Burst Container or Vessel (1074); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
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 balloon catheter, the balloon burst during balloon inflation at 20atm, exceeding the rated burst pressure (rbp) of 18 atm.The target lesion was located in the proximal circumflex (cx) artery which exhibited no tortuosity and moderate calcification.The device was not inspected prior to use and negative prep was performed with no issues noted.The lesion was pre-dilated.The device was not kinked and restraightened during use.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 proximal circumflex lesion was pre-dilated with a 2.5mm non-compliant (nc) balloon, followed by a 3.0mm nc balloon, followed by a 3.5 mm shockwave balloon.A guideliner was then used to deliver a 3.5 x 26 resolute integrity stent.Post-implant of the stent, a 4.5 mm nc balloon was used to dilate the distal and mid section of the stent.The 3.75 x 15 nc sprinter balloon was smoothly delivered to the proximal end of the stent through the guideliner and inflated to 20 atm.The balloon ruptured.The balloon catheter was withdrawn from the patient and it was then discovered that the balloon was no longer attached to the delivery system.On fluoroscopy it was noted that one of the balloon marker bands and the balloon detached during removal and became lodged in the proximal circumflex artery following balloon rupture during inflation at 20 atm.Multiple attempts to rewire the vessel past the lodged balloon and marker band were unsuccessful.No attempt to snare made.The patient was then sent for same day surgery.The patient required coronary artery bypass graft (cabg) x 3 due to the lodged balloon and marker band, which were not removed because of their proximity to the left main artery.The coronary artery bypass graft was successfully completed.No further complications were reported during or after the procedures.
Additional Manufacturer Narrative
Additional information: the balloon burst occurred on the first inflation.The lesion being treated had 70-80% stenosis.The device was not moved or repositioned while inflated.Post-implant of the resolute integrity stent, a 4.5 x 15mm nc sprinter balloon was used to post dilate the distal and mid section of the stent.There were no issues noted with the 4.5 x 15mm nc sprinter balloon.The 3.75 x 15mm nc sprinter balloon was being used to post dilate the proximal portion.It was noted that after the lesion was prepped, stented and the mid and distal portion post dilated, not much residual stenosis was present when the event occurred.No resistance was noted during withdrawal of the device.The physician assessed that the resolute integrity device did not contribute to the 3.75 x 15 nc sprinter balloon burst and detachment and there was no complaint against the resolute integrity stent.Image review: fluoroscopic images confirm the presence of the proximal lesion in the lcx.The vessel was pre-dilated.The reported balloon burst and device detachment could not be confirmed from the images.Final images confirm the presence of the distal device marker band in the vessel.This suggest that the distal end of the catheter has detached.This detached part of the catheter was not removed.The cause of the burst was not identified on the images.One still image received for analysis.Image depicts an nc sprinter device coiled in a clear plastic bag.The device cannot be clearly seen in the image.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 returned for evaluation with a radial balloon burst with the majority of the balloon form the proximal cone to the distal tip detached along with one markerband.The balloon could not be pressurized due to the balloon burst.The distal tip was stretched.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 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: 24412986
• Report Number: 9617601-2026-01365
• Device Sequence Number: 12274930
• Product Code: LOX
• UDI-Device Identifier: 00643169282070
• UDI-Public: (01)00643169282070(17)270625(10)231672552
• 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): 04/08/2026

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
• Operator of Device: Health Professional
• Device Model Number: NCSP37515X
• Device Catalogue Number: NCSP37515X
• Device Lot Number: 231672552
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 03/20/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/13/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown