MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939207050470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the left forearm vessel.A 5.0 x 40, 75 cm gladiator elite balloon was advanced for dilation.However, when the balloon was pressurized to 17 atmospheres, the balloon burst.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A leak test identified a balloon pinhole located approximately 13mm distal of the proximal markerband.The rated burst pressure for this device as per specification is 24 atmospheres.A visual and tactile examination found the shaft of the device to be severely kinked at more than one location.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Markerbands were undamaged in the correct position on the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the left forearm vessel.A 5.0 x40, 75cm gladiator elite balloon was advanced for dilation.However, when the balloon was pressurized to 17 atmospheres, the balloon burst.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.It was further reported that the target lesion was 75% stenosed, non-tortuous, and non-calcified.Furthermore, the balloon ruptured during the first inflation for 10 seconds, and the balloon was removed without any problem using the normal method.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6128757234
• MDR Report Key: 21114386
• Report Number: 2124215-2024-83380
• Device Sequence Number: 15643540
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: 08714729809678
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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 Model Number: H74939207050470
• Device Catalogue Number: H74939207050470
• Device Lot Number: 0032855847
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 61 KG