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	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an arteriovenous (av) fistula in the moderately to severely calcified left upper vessel.A 12.0 x 40, 75cm gladiator balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a non boston scientific device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an arteriovenous (av) fistula in the moderately to severely calcified left upper vessel.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a non boston scientific device.There were no patient complications reported.It was further reported that the balloon was initially inflated at 14 atmospheres for 30 seconds.The balloon ruptured during the second inflation 12 atmospheres for 10 seconds.
Additional Manufacturer Narrative
Device evaluated by mfr: the gladiator elite 12.0 x40, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located at the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complain.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination identified no issues or damage to the tip of the device.
Additional Manufacturer Narrative
Updated b5: describe event or problem.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an arteriovenous (av) fistula in the moderately to severely calcified left upper vessel.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a non boston scientific device.There were no patient complications reported.It was further reported that the balloon was initially inflated at 14 atmospheres for 30 seconds.The balloon ruptured during the second inflation 12 atmospheres for 10 seconds.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13766408
• Report Number: 2134265-2022-02896
• Device Sequence Number: 11735425
• Product Code: LIT
• UDI-Device Identifier: 08714729809555
• UDI-Public: 08714729809555
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2022

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: 08/12/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0027830752
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 03/14/2022; 04/14/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/01/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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: 71 YR
• Patient Sex: Male