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	08/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vascular stenosis at a stoma site.A 5.0 x40, 40cm gladiator elite balloon catheter was selected for dilation.However, after several inflations at less working pressure for few second, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vascular stenosis at a stoma site.A 5.0 x40, 40cm gladiator elite balloon catheter was selected for dilation.However, after several inflations at less working pressure for few second, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a 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.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from the inner shaft and coming out of the tip.The leak coming out from the tip, most probably occurred due to the user applying excessive force to the delivery system when loading the guidewire into device.The tip of the guidewire most likely punctured the inner shaft between the inflation lumen and guidewire lumen.There were no visual rupture or balloon leaks noted on balloon material.A visual and microscopic examination observed damage to the tip of the device.A visual and tactile examination identified a shaft kink 245mm distal from the distal end of the strain relief.A visual examination found no issues or damage to the markerbands of the device.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12539036
• Report Number: 2134265-2021-12159
• Device Sequence Number: 14511038
• Product Code: LIT
• UDI-Device Identifier: 08714729809661
• UDI-Public: 08714729809661
• 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
• Report Date (Section B): 11/16/2021

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: 11/02/2023
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0026284296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 53 KG