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

Model Number	SPL25012X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned for evaluation.There was a detachment on the transition shaft.A kink was noted on the hypotube.The detached distal section was loaded on a 0.014inch guidewire.Bunching and kinked was noted to the detached distal section.The transition shaft material and exchange joint were stretched.The distal shaft was removed from the guidewire with resistance noted.The material at the detachment site was stretched and uneven.No other damage was noted to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
One sprinter legend rx balloon catheter was attempted to be used to treat a 75% calcified, non tortuous lesion in the proximal circumflex.There was no damage noted to the device packaging.There were no issues noted when removing the device from the hoop.It was difficult to remove the protective sheath, there was no difficulty removing the packaging stylette.The device was inspected prior to use with no issues noted.Negative prep was performed with no issues noted.The lesion was not pre-dilated.The traverse guidewire was 300cm.The guidewire was used successfully with other devices prior to the difficulty occurring.The guidewire was front loaded through the wire entry port.There were no difficulties noted when loading the device onto the guidewire.It was reported that there was poor guide wire movement during the procedure.It was attempted to re-position the wire and bring it back to the balloon.It was stated that the traverse wire got stuck in the balloon.The wire and the balloon were then removed as one unit.It was indicated that the sprinter legend device looked damaged due to the attempts to remove the wire.No patient injury reported.

• Brand Name: SPRINTER LEGEND RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 11818399
• Report Number: 9612164-2021-01877
• Device Sequence Number: 3223171
• Product Code: LOX
• UDI-Device Identifier: 00613994902832
• UDI-Public: 00613994902832
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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 Expiration Date: 07/28/2023
• Device Model Number: SPL25012X
• Device Catalogue Number: SPL25012X
• Device Lot Number: 220473851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1