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	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient's internal fistula function was poor, and adequate dialysis was not possible.Internal fistula stenosis occurred.The 75% stenosed target lesion was located in the non-tortuous and moderately calcified left forearm.A 4.0 x40, 40cm gladiator elite was advanced for dilation.During the procedure, on the first inflation at 14 atmospheres at 5 seconds by pump, the balloon ruptured.The device was removed and replaced for another of the same model to complete the procedure.No complications reported, and patient status was stable.
Additional Manufacturer Narrative
Device received by mfr.: the device was returned for analysis and underwent a visual and tactile examination.It was found that a longitudinal tear was identified in the balloon material.The tear measured 30mm in length and extended from a position 3mm proximal of the distal markerband to 4mm distal of the proximal markerband.There was no damage found on the tip, shaft, and markerbands of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The patient's internal fistula function was poor, and adequate dialysis was not possible.Internal fistula stenosis occurred.The 75% stenosed target lesion was located in the non-tortuous and moderately calcified left forearm.A 4.0 x40, 40cm gladiator elite was advanced for dilation.During the procedure, on the first inflation at 14 atmospheres at 5 seconds by pump, the balloon ruptured.The device was removed and replaced for another of the same model 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: 19556948
• Report Number: 2124215-2024-36099
• Device Sequence Number: 20036706
• Product Code: LIT
• UDI-Device Identifier: 08714729809609
• UDI-Public: 08714729809609
• 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): 07/19/2024

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: 10/20/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030392046
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 74 KG