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

Model Number	24686
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, difficulty to remove, balloon detachment, and additional intervention occurred.The 70-80% stenosed target lesion was located in the non-tortuous and non-calcified fistula.A 10.0 x80, 75cm gladiator balloon catheter was selected for treatment.The pressure was brought up 3 times with the previous being 18-20 mmhg.During this procedure, on the third inflation at 20 atmospheres for 15 seconds, the balloon ruptured.An attempt was made to remove the balloon, but only the proximal portion was able to be withdrawn through a 6fr 7cm sheath.The distal part was pulled to the access site where an incision was made so a surgical intervention would be performed by making a large upsizing of the venotomy to get the balloon and sheath out without the balloon fracturing.There was an in-room cut-down and widening to ensure capture of everything.The remainder of the balloon was withdrawn but everted upon itself.A 7fr 11cm sheath was used to try to obtain hemostasis but was unsuccessful, thus, a 10fr 11cm sheath was used.Pressure was applied to the fistula at the wrist and was sutured.Patient was discharged in a stable condition and is expected to fully recover.There were no complications reported.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19942648
• Report Number: 2124215-2024-48284
• Device Sequence Number: 7319462
• Product Code: LIT
• UDI-Device Identifier: 08714729826415
• UDI-Public: 08714729826415
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2026
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0031452252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/08/2024
• Date Device Manufactured: 04/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown