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	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The more than 50% stenosed target lesion was located in the mildly tortuous and non-calcified cephalic vein.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during second inflation at 22 atmospheres for 60 seconds, the balloon ruptured laterally.The balloon was pulled back to the sheath, and the guide wire, sheath and balloon were withdrawn together.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The more than 50% stenosed target lesion was located in the mildly tortuous and non-calcified cephalic vein.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during second inflation at 22 atmospheres for 60 seconds, the balloon ruptured laterally.The balloon was pulled back to the sheath, and the guide wire, sheath and balloon were withdrawn together.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.The device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A full balloon circumferential tear was identified located approximately 17mm distal of the proximal balloon markerband.The distal section of the balloon material had been pulled distally passed the distal markerband and towards the tip of the device.This type of damage potentially occurred when the device was being withdrawn through the sheath.A visual examination observed no damage to the tip of the device.A visual and tactile examination found that the shaft was detached approximately 440mm proximal from the distal tip.Multiple shaft kink.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified with the device and 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: 19220942
• Report Number: 2124215-2024-26205
• Device Sequence Number: 6904111
• Product Code: LIT
• UDI-Device Identifier: 08714729809722
• UDI-Public: 08714729809722
• 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): 07/01/2024

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: 0030088713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/01/2024
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 55 KG