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

Model Number	24686
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified cephalic vein.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, on the first inflation when the pressure reached 20 atmospheres, the balloon burst.It was when the device was simply pulled out was the burst noted.A different model was used to complete the procedure.No complications reported, and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis and underwent a visual and tactile examination.A longitudinal tear was identified in the balloon material.The tear measured 30mm in length and extended from a position 10 mm proximal of the proximal markerband to 15mm proximal of the distal markerband.There were no issues found on the tip, shaft, and markerbands of this device.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified cephalic vein.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, on the first inflation when the pressure reached 20 atmospheres, the balloon burst.It was when the device was simply pulled out was the burst noted.A different model was used to complete the procedure.No complications reported, and patient status was stable.

• 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: 19731108
• Report Number: 2124215-2024-42973
• Device Sequence Number: 8206890
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: 08714729809791
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 09/05/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030088777
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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 Sex: Unknown