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

Model Number	H74939207060440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).
Event or Problem Description
It was reported that the balloon was ruptured.The stenosed target lesion was identified in the arteriovenous fistula of the left upper limb.A 6.0 x 40 mm gladiator elite balloon catheter, with a length of 40 cm, was advanced over the guidewire to dilate the stenosis on the venous side of the artificial blood vessel.During the procedure, the balloon was inflated initially at a pressure of 10-22 atmospheres for a duration of 30-60 seconds.It was then inflated a second time at 22-24 atmospheres.During this second inflation, a drop in pressure was observed, suggesting a possible rupture of the balloon.Upon retrieval, the tip of the balloon was confirmed to be burst.The device was removed successfully and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).Device evaluated by mfr: the device was returned 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 and the device was inflated to its rated burst pressure with no leaks or issues noted.The rated burst pressure for this device is 24 atmospheres as per gladiator elite specification.A visual examination observed no damage to the tip of the device.A visual and tactile examination of the shaft of the device found no issues.A visual examination found no issues or damage to the markerbands of the device.
Event or Problem Description
It was reported that the balloon was ruptured.The stenosed target lesion was identified in the arteriovenous fistula of the left upper limb.A 6.0 x 40 mm gladiator elite balloon catheter, with a length of 40 cm, was advanced over the guidewire to dilate the stenosis on the venous side of the artificial blood vessel.During the procedure, the balloon was inflated initially at a pressure of 10-22 atmospheres for a duration of 30-60 seconds.It was then inflated a second time at 22-24 atmospheres.During this second inflation, a drop in pressure was observed, suggesting a possible rupture of the balloon.Upon retrieval, the tip of the balloon was confirmed to be burst.The device was removed successfully and the procedure was completed with another of the same device.There were no patient 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: 20662133
• Report Number: 2124215-2024-70764
• Device Sequence Number: 8208150
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2024

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: 09/04/2026
• Device Model Number: H74939207060440
• Device Catalogue Number: H74939207060440
• Device Lot Number: 0032355043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 11/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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
• Patient Sex: Male