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

Model Number	24686
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with cephalic arch stenosis and underwent fistulagram.A 10.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.However, during the initial inflation at 14 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a gladiator device was returned for analysis.A visual examination of the balloon identified that it was not folded, which indicates that the balloon has been subjected to positive pressure.A full balloon circumferential tear was located approximately 25mm distal of the proximal markerband.Part of the balloon was pulled in a distal direction over the distal tip.A visual examination of the tip identified no issues.A visual and tactile examination of the shaft identified no issues.A visual examination of the markerbands identified no damage.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with cephalic arch stenosis and underwent fistulagram.A 10.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.However, during the initial inflation at 14 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.No patient complications were reported.

• 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: 17799379
• Report Number: 2124215-2023-51972
• Device Sequence Number: 7183591
• Product Code: LIT
• UDI-Device Identifier: 08714729809517
• UDI-Public: 08714729809517
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: 02/14/2026
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0031046799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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 Sex: Unknown