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	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with pain in an internal fistula in the left upper arm accompanied by increased venous pressure during dialysis.Ultrasound revealed stenosis and calcification of the autologous arteriovenous internal fistula anastomosis ostial of the left elbow, and stenosis in the distal end of the stent of the subclavian vein.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the first inflation at 4 atmospheres, the balloon ruptured.The device was removed.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with pain in an internal fistula in the left upper arm accompanied by increased venous pressure during dialysis.Ultrasound revealed stenosis and calcification of the autologous arteriovenous internal fistula anastomosis ostial of the left elbow, and stenosis in the distal end of the stent of the subclavian vein.A 12.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the first inflation at 4 atmospheres, the balloon ruptured.The device was removed.No patient complications were reported and the patient status was stable.It was further reported that the target lesion was moderately tortuous and moderately calcified.The procedure was cancelled due to no available device replacement.
Additional Manufacturer Narrative
Updated b5: describe event or problem.

• 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: 15103853
• Report Number: 2124215-2022-26962
• Device Sequence Number: 17440149
• Product Code: LIT
• UDI-Device Identifier: 08714729809555
• UDI-Public: 08714729809555
• 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): 08/09/2022

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: 04/07/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0027102253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 50 KG