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	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the internal arteriovenous fistula.A 4.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation, however, during the procedure the balloon ruptured.The device was removed and the procedure was completed with another of the same device.There were no complications reported and the and the patient is stable.
Additional Manufacturer Narrative
E1 initial reporter address (b)(6).E1 initial reporter phone: (b)(6).B5 describe event or problem updated.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the internal arteriovenous fistula.A 4.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation, however, during the procedure the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.There were no complications reported and the and the patient is stable.It was further reported that the stenosed target lesion was 80%, located in the moderately tortuous and severely calcified internal arteriovenous fistula.Inflation was performed 6 times, however the balloon ruptured during the sixth inflation at 20 atmospheres in 40-50 seconds duration.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).B5 describe event or problem updated device evaluated by mfr.: gladiator elite 4.0 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.A balloon longitudinal tear was identified beginning approximately 3mm proximal of the proximal markerband and extending approximately 43mm distally across the balloon material.As per gladiator specification the rated burst pressure for this device is 24 atmospheres.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual examination identified no damage to the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the internal arteriovenous fistula.A 4.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation, however, during the procedure the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.There were no complications reported and the and the patient is stable.It was further reported that the stenosed target lesion was 80%, located in the moderately tortuous and severely calcified internal arteriovenous fistula.Inflation was performed 6 times, however the balloon ruptured during the sixth inflation at 20 atmospheres in 40-50 seconds duration.

• 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: 17640608
• Report Number: 2124215-2023-45661
• Device Sequence Number: 5633164
• Product Code: LIT
• UDI-Device Identifier: 08714729809609
• UDI-Public: 08714729809609
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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: 06/22/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029642576
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 08/30/2023; 10/09/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/08/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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: 31 YR
• Patient Sex: Male
• Patient Weight: 76 KG