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	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty (pta) balloon dilation.The stenosed target lesion was located in the arteriovenous fistula.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported, and the patient's status was stable.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty (pta) balloon dilation.The stenosed target lesion was located in the arteriovenous fistula.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported, and the patient's status was stable.It was further reported that the stenosed target lesion was 80-90% located in the moderately tortuous and severely calcified arteriovenous fistula.The balloon was inflated six times at 20 atmospheres for 50-60 seconds, and the device was removed by the catheter sheath.
Additional Manufacturer Narrative
E1: initial reporter address 1:(b)(6).Device evaluated by mfr: gladiator elite 6.0 x40, 40cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 24 atmospheres for 30 seconds using digital timer without issue.A vacuum was then applied.The inflation device was verified at 24 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure of 24 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per gladiator specification the rated burst pressure for this device is 24 atmospheres.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from kinks or damage.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty (pta) balloon dilation.The stenosed target lesion was located in the arteriovenous fistula.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported, and the patient's status was stable.It was further reported that the stenosed target lesion was 80-90% located in the moderately tortuous and severely calcified arteriovenous fistula.The balloon was inflated six times at 20 atmospheres for 50-60 seconds, and the device was removed by the catheter sheath.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16588633
• Report Number: 2124215-2023-13288
• Device Sequence Number: 5729110
• Product Code: LIT
• UDI-Device Identifier: 08714729809722
• UDI-Public: 08714729809722
• 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,Followup
• Report Date (Section B): 04/18/2023

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: 04/27/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029302970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 04/13/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/03/2023; 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG