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

Model Number	SPL25020X
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An attempt was made to use one sprinter legend coronary balloon catheter to treat a lesion with chronic total occlusion in the distal left anterior descending (lad) artery.It was not difficult to remove the protective sheath or the packaging stylette.The device was inspected with no issues.Negative prep was performed with no issues.The lesion was pre-dilated throughout multiple times with a 1mm non-medtronic balloon without issue.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.It was reported that balloon deflation difficulties occurred, and the device would not deflate at the lesion site.Difficulties were noted during inflation of the device, as the balloon did not inflate evenly.An inflation pressure of 10 atm was applied, and deflation difficulties occurred after the first inflation.The balloon failed to deflate and remained wedged within the artery.Attempts were made to try and deflate and reinflate the balloon, but this did not change anything.The device was not moved or repositioned while inflated.The balloon was inflated beyond the rated burst pressure to try and intentionally burst the balloon to facilitate successful removal.The balloon was eventually removed after advancing a non-medtronic guide extension catheter (gec) to the balloon and then using the back end of a wire to pierce the balloon.This resulted in contrast disappearing from the balloon, which then was withdrawn into the gec.The balloon was removed successfully, and the case was completed successfully.The patient is alive with no further injury.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.
Additional Manufacturer Narrative
Additional information - image analysis: one still fluoroscopic images as provided with this event.The image appears to show the vessel and balloon post burst of the balloon with the guidewire.The balloon appears to have burst with a radial burst as there is bunching of balloon material between the inner shaft markerbands.The guide extension catheter is evident distal to the guide catheter in the proximal vessel.The cause of the reported deflation difficulties cannot be determined from the image provided.Annex d code added.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: 20425681
• Report Number: 9612164-2024-04635
• Device Sequence Number: 8441281
• Product Code: LOX
• UDI-Device Identifier: 00613994902566
• UDI-Public: 00613994902566
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 11/08/2024

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: SPL25020X
• Device Catalogue Number: SPL25020X
• Device Lot Number: 228820034
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/08/2024
• Date Device Manufactured: 05/14/2024
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 110 KG