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	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon was broken.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon was broken.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was severely tortuous and moderately calcified with 80-90% stenosis.The balloon ruptured during sixth inflation at 30 atmospheres for 50 seconds and was completely removed from the patient's body.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon was broken.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the target lesion was severely tortuous and moderately calcified with 80-90% stenosis.The balloon ruptured during sixth inflation at 30 atmospheres for 50 seconds and was completely removed from the patient's body.
Additional Manufacturer Narrative
Device evaluated by mfr.: gladiator elite 6.0 x80, 40cm, was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 9mm distal of the proximal markerband and extending approximately 63mm distally across the balloon material.No other issues were identified with the balloon material.The rated burst pressure for this device is 24 atmospheres.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found the shaft of the device to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues or damage to the tip of the device.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16404220
• Report Number: 2124215-2023-07478
• Device Sequence Number: 17508210
• Product Code: LIT
• UDI-Device Identifier: 08714729809746
• UDI-Public: 08714729809746
• 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): 04/10/2023

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: 03/08/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029009412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 04/06/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 02/27/2023; 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 62 KG