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	02/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 6.0 x80, 75cm gladiator balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 6.0 x80, 75cm gladiator balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon ruptured during the first inflation at less working pressure and was simply removed as a whole.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 6.0 x80, 75cm gladiator balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon ruptured during the first inflation at less working pressure and was simply removed as a whole.
Additional Manufacturer Narrative
Device evaluated by mfr.: a gladiator device was returned for analysis.A complete balloon circumferential tear was identified located approximately 70mm distal of the proximal balloon sleeve.The distal section of the balloon tear including a section of the inner shaft, markerbands and tip was not returned for analysis.The rated burst pressure for this device is 24 atmospheres.A visual and tactile examination found the shaft of the device to have completely detached.The break was located approximately 8mm distal of the proximal balloon sleeve.The detached section of shaft that was not returned along with the two markerbands, part of the balloon and distal tip.There were also multiple shaft kinks and stretching noted.

• 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: 13691348
• Report Number: 2134265-2022-02542
• Device Sequence Number: 5295311
• Product Code: LIT
• UDI-Device Identifier: 08714729809753
• UDI-Public: 08714729809753
• 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): 04/11/2022

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: 01/25/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0026687728
• 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: 02/24/2022
• Supplement Date Received by Manufacturer: 03/09/2022; 04/07/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 03/15/2022; 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 58 KG