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	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left forearm arteriovenous fistula.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon was noted to be broken.After the balloon was removed, the physician was informed that there was a damage of about 3mm in length.Upon careful observation, it was suspected that the crack was caused by the situation that tension was excessive, and the balloon was ruptured and could not be restored.The hand-washing nurse and the traveling nurse immediately searched around the stage and the floor, and no missing parts were found.The physician immediately carefully examined the relevant areas of the operating field with ultrasound and confirmed through imaging that there was no foreign body in the patient.The procedure was completed with this device.No patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the gladiator was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A circumferential tear was noted on the balloon.From the circumferential tear, there was a longitudinal tear noted on each part of the balloon.A visual examination observed damage to the tip of the device.A visual and tactile examination found multiple shaft kinks along the length of the shaft.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left forearm arteriovenous fistula.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon was noted to be broken.After the balloon was removed, the physician was informed that there was a damage of about 3mm in length.Upon careful observation, it was suspected that the crack was caused by the situation that tension was excessive, and the balloon was ruptured and could not be restored.The hand-washing nurse and the traveling nurse immediately searched around the stage and the floor, and no missing parts were found.The physician immediately carefully examined the relevant areas of the operating field with ultrasound and confirmed through imaging that there was no foreign body in the patient.The procedure was completed with this device.No patient complications 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: 18827149
• Report Number: 2124215-2024-11916
• Device Sequence Number: 7786267
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 0030392106
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/12/2024
• 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: 51 YR
• Patient Sex: Male