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

Model Number	SPR1510W
Medical Device Problem Codes	Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure involving one sprinter balloon catheter, the balloon ruptured and then became stuck in the vessel.Removal difficulties were encountered following balloon inflation.The device detached at the balloon during removal.A non-medtronic guidewire and non-medtronic micro catheter were used in an attempt to snare the balloon however when the physician proceeded to take out the guidewire, the balloon dislodged further into the vessel and was unable to be retrieved.The lesion being treated was moderately tortuous and severely calcified located in the mid ramus with 95% stenosis.The device was used to pre-dilate the lesion.The device was not moved or re-positioned while inflated.The device was inspected prior to use and negatively prepped with no issues.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was encountered when advancing the device.Excessive force was not used during delivery.A proper amount of force to withdraw the device.The device was not kinked and re-straightened during use.The patient's pressure became elevated due to occlusion/disrupting in the artery.The patient sustained a st-elevation myocardial infarction (stemi). no further 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
Additional information: the patient is reported to be healthy and stable with no adverse effects from this issue.Correction: annex e 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.
Additional Manufacturer Narrative
Product analysis: the device returned for evaluation.Upon device return, it was observed that the proximal portion of the balloon, including part of the tip, was detached from the device.The remaining balloon showed signs of inflation, as the balloon folds were expanded.Due to the condition of the device, it was not possible to confirm whether a burst had occurred.Blood was visible within the balloon and the inflation lumen.The markerbands were also detached from the inner member.No other damage was noted.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: SPRINTER OTW
• 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: 22629079
• Report Number: 9617601-2025-00701
• Device Sequence Number: 8936702
• Product Code: LOX
• UDI-Device Identifier: 00643169850323
• UDI-Public: (01)00643169850323(17)260515(10)228885312
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2025

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 Expiration Date: 05/15/2026
• Device Model Number: SPR1510W
• Device Catalogue Number: SPR1510W
• Device Lot Number: 228885312
• 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: 07/10/2025
• Supplement Date Received by Manufacturer: 07/31/2025; 11/04/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/11/2025; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 67 KG