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

Model Number	SPL12515X
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that one sprinter legend balloon catheter detached during removal of the device from the patient.The lesion being treated was moderately tortuous, moderately calcified with 90% stenosis in the mid left main (lm) coronary artery and obtuse marginal (om).The device was inspected prior to use with no issues.Negative prep was performed with no issues.The device was being used to pre-dilate the lesion and 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.The device was inserted into the mid circumflex coronary in preparation for stent placement.When placing the balloon, some maneuverability was required but nothing that would be unexpected.The balloon was inflated to 20 atm for 30 seconds.After inflation an attempt was made to withdraw the balloon at which time the balloon disconnected from the wire breaking free.Multiple attempts were made to retrieve the balloon without success.Balloons and wires were inserted to try and remove the detached device and get it to a place where it could be snared.However, the detached balloon remains in the patient.The balloon ended up in a distal side branch.An intra-aortic balloon pump was inserted.St-elevation changes were noted in multiple leads and the patient has an infarct.Cardiothoracic surgery was consulted, and the patient was transferred to recovery.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: resistance was noted during attempted withdrawal of the device, as it was needed to pull hard to remove the catheter.It was possible to get a balloon beside the detached balloon portion, and the wire that had broken off the balloon was gently removed.As the detached balloon was being removed alongside the wire the balloon part slipped off the wire and migrated down to a smaller vessel in the patient and closed that small vessel.The patient was sent to the intensive care units (icu) for observation and the infarct was treated medically.The detached portion of the device still remains in the patient.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 catheter fractured at the proximal end of the balloon with some balloon left on the catheter.The marker band was visible on the balloon in the patient after the detachment.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 guide wire did not detach.Correction: it was confirmed that it was the left circumflex (cx) artery not the left main (lm) that was treated.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 codes.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 LEGEND 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: 21695681
• Report Number: 9612164-2025-01529
• Device Sequence Number: 18336466
• Product Code: LOX
• UDI-Device Identifier: 00643169271777
• UDI-Public: 00643169271777
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K103095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/17/2025

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 Model Number: SPL12515X
• Device Catalogue Number: SPL12515X
• Device Lot Number: 227752003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 04/28/2025; 05/29/2025; 06/16/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/25/2025; 05/07/2025; 05/30/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White