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	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.After a 7fr non-boston scientific (bsc) introducer sheath was introduced and a 180cm non-bsc guidewire crossed the lesion, a 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation at 20 atmospheres (atm), the balloon ruptured.Another 7.0 x80, 75cm gladiator elite balloon catheter was advanced and inflated at 16 atm; but it also ruptured.Both balloons were removed and the procedure was completed with a 7x40 non-bsc device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a gladiator device 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 longitudinal tear was identified in the balloon material.The tear measured 55mm in length and extended from a position 23mm proximal of the proximal markerband to 3 mm distal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.After a 7fr non-boston scientific (bsc) introducer sheath was introduced and a 180cm non-bsc guidewire crossed the lesion, a 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during first inflation at 20 atmospheres (atm), the balloon ruptured.Another 7.0 x80, 75cm gladiator elite balloon catheter was advanced and inflated at 16 atm; but it also ruptured.Both balloons were removed and the procedure was completed with a 7x40 non-bsc device.No patient complications were reported.

• 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: 14958453
• Report Number: 2124215-2022-24867
• Device Sequence Number: 6905637
• Product Code: LIT
• UDI-Device Identifier: 08714729809838
• UDI-Public: 08714729809838
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 07/21/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0027712418
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE USED: 180CM COOK ROADRUNNER WIRE; GUIDEWIRE USED: 180CM COOK ROADRUNNER WIRE; INFLATION DEVICE USED: BARD PRESTO; INFLATION DEVICE USED: BARD PRESTO; INTRODUCER SHEATH USED: 7FR BS SUPER SHEATH; INTRODUCER SHEATH USED: 7FR BS SUPER SHEATH
• Patient Sex: Unknown