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

Model Number	24686
Medical Device Problem Codes	Material Rupture (1546); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured and tip damaged occurred.The target location was located in the left upper extremity vessel.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon was inflated for approximately 30 to 60 seconds at 22 to 24 atmospheres for the second time.It was discovered that the balloon had ruptured.Upon removal, it was observed that the tip of the balloon was broken.The procedure was then completed using another the same device.No complications were reported, and the patient was stable.
Event or Problem Description
It was reported that balloon ruptured and tip damaged occurred.The target location was located in the left upper extremity vessel.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon was inflated for approximately 30 to 60 seconds at 22 to 24 atmospheres for the second time.It was discovered that the balloon had ruptured.Upon removal, it was observed that the tip of the balloon was broken.The procedure was then completed using another the same device.No complications were reported, and the patient was stable.It was further reported that the target lesion was located was 78% stenosed and was located in the severely tortuous and severely calcified left upper extremity vessel.Additionally, it was noted that no tip fracture or detachment occurred.
Additional Manufacturer Narrative
Device evaluated by mfr: the gladiator elite was returned for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 16mm distal of the proximal markerband.The distal section of balloon material was also torn longitudinally beginning at the circumferential tear and extending for approximately 12mm distally.No other issues were noted with the balloon material.As per specification 90519237 the rated burst pressure for this device is 24 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be kinked at more than one location.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon ruptured and tip damaged occurred.The target location was located in the left upper extremity vessel.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon was inflated for approximately 30 to 60 seconds at 22 to 24 atmospheres for the second time.It was discovered that the balloon had ruptured.Upon removal, it was observed that the tip of the balloon was broken.The procedure was then completed using another the same device.No complications were reported, and the patient was stable.It was further reported that the target lesion was located was 78% stenosed and was located in the severely tortuous and severely calcified left upper extremity vessel.Additionally, it was noted that no tip fracture or detachment occurred.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19867984
• Report Number: 2124215-2024-47116
• Device Sequence Number: 20858717
• Product Code: LIT
• UDI-Device Identifier: 08714729809616
• UDI-Public: 08714729809616
• 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,Followup
• Report Date (Section B): 09/18/2024

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: 11/07/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030498830
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 08/22/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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: 68 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG