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	05/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in a vessel in the arm.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon burst without reaching the rated burst pressure.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in a vessel in the arm.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon burst without reaching the rated burst pressure.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the lesion was severely stenosed.The balloon inflated once in a less working pressure for a few seconds and the device was completely removed from the patient.
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in a vessel in the arm.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon burst without reaching the rated burst pressure.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.It was further reported that the lesion was severely stenosed.The balloon inflated once in a less working pressure for a few seconds and the device was completely removed from the patient.
Additional Manufacturer Narrative
Device evaluated by mfr: a gladiator device batch # 262000623, 20 atm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 20 atmospheres for 30 seconds using digital timer: g24609, without issue.A vacuum was then applied.The inflation device was verified at 20 atmospheres, before and after use with calibrated pressure gauge g19252.This inflation to rate of burst pressure of 20 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per gladiator specification the rated burst pressure for this device is 20 atmospheres.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from kinks or damage.

• 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: 14575406
• Report Number: 2134265-2022-05854
• Device Sequence Number: 6113392
• Product Code: LIT
• UDI-Device Identifier: 08714729809784
• UDI-Public: 08714729809784
• 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): 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: 10/16/2023
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0026200623
• 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: 05/17/2022
• Supplement Date Received by Manufacturer: 06/07/2022; 08/05/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 06/13/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2020
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG