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	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with a narrow arteriovenous fistula in the right upper limb.The target lesion was located in the stenosed basilic vein in the upper arm.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.The balloon was inflated twice at 10 atmospheres (atm) and 22 atm respectively for 30-60 seconds; however, during third inflation at 24-26 atm, the balloon ruptured.The device was removed and found to be damaged.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
Updated: b5: describe event or problem e1: initial reporter's address and email.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with a narrow arteriovenous fistula in the right upper limb.The target lesion was located in the stenosed basilic vein in the upper arm.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.The balloon was inflated twice at 10 atmospheres (atm) and 22 atm respectively for 30-60 seconds; however, during third inflation at 24-26 atm, the balloon ruptured.The device was removed and found to be damaged.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was 80% stenosed, moderately calcified and mildly tortuous.

• 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: 15879556
• Report Number: 2124215-2022-49667
• Device Sequence Number: 5446395
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: 08714729809678
• 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): 12/14/2022

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: 09/01/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0027951432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 60 KG