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

Model Number	24686
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The severely stenosed target lesion was located in an arteriovenous fistula in a mildly tortuous and non-calcified vessel.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during second inflation at 22 atmospheres for few seconds, the balloon ruptured.The device was removed and a pinhole was noted on the balloon material.The procedure was completed with another of same device.No patients complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: a gladiator was returned for analysis.A visual examination identified that the balloon section of the device, including the markerbands and tip was detached from the device and not returned with the device.A visual and tactile examination of the shaft of the device found the shaft to be detached 677mm distal from the distal end of the strain relief.The shaft was also noted to be stretched and kinked.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The severely stenosed target lesion was located in an arteriovenous fistula in a mildly tortuous and non-calcified vessel.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during second inflation at 22 atmospheres for few seconds, the balloon ruptured.The device was removed and a pinhole was noted on the balloon material.The procedure was completed with another of same device.No patients complications were reported and the patient status was stable.

• 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: 15217407
• Report Number: 2124215-2022-30173
• Device Sequence Number: 12234069
• 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
• Report Date (Section B): 09/16/2022

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: 08/25/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0027908291
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG