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	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access at fistula site was obtained.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, while applying pressure on the device, the balloon ruptured.The procedure was completed with another of same device.No patient complications reported, and the patient condition was stable.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.E1: initial reporter facility name: (b)(6) device evaluated by mfr.: gladiator elite 6.0 x40, 40cm, was received for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.Two complete balloon circumferential tears were identified.The first tear was located approximately 15mm distal of the proximal balloon bond.The second tear was located approximately 17mm proximal of the distal balloon bond.From the proximal circumferential tear, the balloon was also torn longitudinally for approximately 5mm.The distal section of balloon material had been pulled distally over the tip of the device.The center section balloon material was not returned for analysis.No other issues were noted with the balloon material.As per gladiator specification, the rated burst pressure for this device is 24 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.Both markerbands were present on the shaft of the device.The distal markerband had moved proximally on the shaft most probably due the damage to the shaft.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access at fistula site was obtained.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, while applying pressure on the device, the balloon ruptured.The procedure was completed with another of same device.No patient complications reported, and the patient condition was stable.It was further reported that the target lesion diameter was 2.0mm with length of 10mm located in the non-tortuous and mildly calcified vessel.The device was inflated twice at 20 and 24 atmospheres respectively.However, on the third inflation at 24 atmospheres, the balloon ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access at fistula site was obtained.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, while applying pressure on the device, the balloon ruptured.The procedure was completed with another of same device.No patient complications reported, and the patient condition was stable.It was further reported that the target lesion diameter was 2.0mm with length of 10mm located in the non-tortuous and mildly calcified vessel.The device was inflated twice at 20 and 24 atmospheres respectively.However, on the third inflation at 24 atmospheres, the balloon ruptured.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older b5.Describe event or problem- updated.E1: initial reporter facility name: (b)(6).

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16344379
• Report Number: 2124215-2023-05812
• Device Sequence Number: 20441119
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2023

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: 06/02/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029498032
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 02/10/2023; 03/14/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/13/2023; 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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