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	11/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately calcified vesse in the upper extremity.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The balloon was successfully removed from the patient.The procedure was completed with another of same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
A gladiator device batch # 27484029 14 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.A longitudinal tear was identified in the balloon material.The tear measured 53mm in length and extended from a position 6mm proximal of the proximal markerband to 7mm distal of the distal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic 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.The target lesion was located in the moderately calcified vesse in the upper extremity.A 12.0 x40, 75cm gladiator balloon catheter was advanced for dilation.However, during inflation at 12 atmospheres, the balloon ruptured.The balloon was successfully removed from the patient.The procedure was completed with another of same device.There were no patient complications nor injuries 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12987398
• Report Number: 2134265-2021-15662
• Device Sequence Number: 14705994
• 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
• Report Date (Section B): 01/21/2022

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: 06/13/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0027484029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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