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	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for balloon dilation of vascular stenosis at fistula.The 50% stenosed target lesion with a bend of > 90 degrees was located in the severely tortuous and moderately calcified vessel.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, during inflation at 15-20 atmospheres for 30 seconds the balloon ruptured and a pinhole was noted.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
A2- age at time of event: 18 years or older.Device evaluated by mfr.: a gladiator device 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 at the proximal balloon sleeve.The balloon was also torn longitudinally beginning at the circumferential tear and extending approximately 90mm distally across the balloon material.No other issues were noted with the balloon.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.A visual examination found both markerbands to be undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for balloon dilation of vascular stenosis at fistula.The 50% stenosed target lesion with a bend of > 90degrees was located in the severely tortuous and moderately calcified vessel.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, during inflation at 15-20 atmospheres for 30 seconds, the balloon ruptured and a pinhole was noted.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 there were two 7.0 x80, 75cm gladiator elite balloon catheters used during the procedure and were damaged.The balloon catheters got damaged on the second time it was pressurized.
Additional Manufacturer Narrative
A2- age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for balloon dilation of vascular stenosis at fistula.The 50% stenosed target lesion with a bend of > 90degrees was located in the severely tortuous and moderately calcified vessel.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, during inflation at 15-20 atmospheres for 30 seconds, the balloon ruptured and a pinhole was noted.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 there were two 7.0 x80, 75cm gladiator elite balloon catheters used during the procedure and were damaged.The balloon catheters got damaged on the second time it was pressurized.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16060222
• Report Number: 2124215-2022-55017
• Device Sequence Number: 2019842
• Product Code: LIT
• UDI-Device Identifier: 08714729809838
• UDI-Public: 08714729809838
• 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): 02/01/2023

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: 02/08/2023
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0025180152
• 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: 12/21/2022
• Supplement Date Received by Manufacturer: 12/29/2022; 01/30/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 01/16/2023; 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2020
• 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 Sex: Unknown