MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24686
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred requiring surgical intervention.The 40% stenosed target lesion with a <45 degrees bend was located in the mildly tortuous and mildly calcified arteriovenous fistula of left upper limb artificial vessel.After a guidewire was crossed the lesion, a 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, on the first inflation at 10 to 20 atmospheres for 30 to 60 seconds, the pressure decreased and the balloon burst.When the device was removed, it was found out that there was a fragment left in the blood vessel.The residual end was removed by emergency incision of the blood vessel.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.
Event or Problem Description
It was reported that balloon rupture occurred requiring surgical intervention.The 40% stenosed target lesion with a <45 degrees bend was located in the mildly tortuous and mildly calcified arteriovenous fistula of left upper limb artificial vessel.After a guidewire was crossed the lesion, a 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, on the first inflation at 10 to 20 atmospheres for 30 to 60 seconds, the pressure decreased and the balloon burst.When the device was removed, it was found out that there was a fragment left in the blood vessel.The residual end was removed by emergency incision of the blood vessel.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: gladiator elite 7.0 x40, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 35mm distal of the proximal balloon sleeve.This type of damage most probably occurred when the device was being withdrawn through the sheath.The rated burst pressure for this device as per gladiator specification is 20 atmospheres.A visual and tactile examination found the shaft of the device to have completely detached at approximately 5mm distal of the proximal balloon sleeve.The distal section of shaft including the distal section of balloon material, the distal markerband and the tip of the device were not returned for analysis.The shaft was also found to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual examination found one of the markerbands to have completely detached from the device.The detached markerband was located inside the proximal section balloon material during analysis.The second markerband including the distal section of shaft which detached was not returned for analysis.

• 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: 15756222
• Report Number: 2124215-2022-43492
• Device Sequence Number: 4874170
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: 08714729809791
• 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): 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029302980
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 58 KG