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	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in internal arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during procedure, the balloon burst.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in internal arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during procedure, the balloon burst.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable post-procedure.It was further reported that the 80-90% stenosed target lesion was severely tortuous and moderately calcified.Furthermore, the balloon burst during the seventh inflation at 20 atmospheres for 50-60 seconds, and the balloon was removed completely.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr.: gladiator elite 7.0 x80, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning at the proximal markerband and extending approximately 69mm distally across the balloon material.As per gladiator specification the rated burst pressure for this device is 20 atmospheres.Tactile examination identified no issues on the markerbands.There were no kinks/damage in the shaft and no damaged observed to the tip during the analysis.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in internal arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during procedure, the balloon burst.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable post-procedure.It was further reported that the 80-90% stenosed target lesion was severely tortuous and moderately calcified.Furthermore, the balloon burst during the seventh inflation at 20 atmospheres for 50-60 seconds, and the balloon was removed completely.

• 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: 17360878
• Report Number: 2124215-2023-38027
• Device Sequence Number: 5205891
• 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,Followup
• Report Date (Section B): 08/28/2023

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: 0029302988
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/21/2023; 08/24/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 07/24/2023; 08/28/2023
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 82 KG