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

Model Number	H74939207060470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 6.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.A 5f mini-catheter sheath was successfully inserted into the left radial artery, 1 cm proximal to the wrist joint, using the seldingermethod.A 6f vascular sheath was then inserted with the 6f guide wire, and 3000u of heparin was administered intravenously.The guide wire was smoothly advanced to the proximal end of the cephalic vein.The 4 x 40mm, 75cm gladiator balloon was delivered and inflated at 24 atm for 30 seconds to treat the occlusion and stenosis in the cephalic vein.However, a follow-up ultrasound revealed insufficient dilation, so a 6 x 40mm, 75cm gladiator balloon was used.During inflation to 20 atm, the pressure dropped, indicating a balloon was broken.A replacement balloon was used, and the pressure was increased to 24 atm for 30 seconds, the occlusion and stenosis of cephalic vein were fully dilated.After withdrawing the catheter and guide wire, the sheath was removed, and local pressure bandaging was applied.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.A 6.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.A 5f mini-catheter sheath was successfully inserted into the left radial artery, 1 cm proximal to the wrist joint, using the seldinger method.A 6f vascular sheath was then inserted with the 6f guide wire, and 3000u of heparin was administered intravenously.The guide wire was smoothly advanced to the proximal end of the cephalic vein.The 4 x 40mm, 75cm gladiator balloon was delivered and inflated at 24 atm for 30 seconds to treat the occlusion and stenosis in the cephalic vein.However, a follow-up ultrasound revealed insufficient dilation, so a 6 x 40mm, 75cm gladiator balloon was used.During inflation to 20 atm, the pressure dropped, indicating a balloon was broken.A replacement balloon was used, and the pressure was increased to 24 atm for 30 seconds, the occlusion and stenosis of cephalic vein were fully dilated.After withdrawing the catheter and guide wire, the sheath was removed, and local pressure bandaging was applied.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the gladiator was returned for analysis.A visual examination revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 42 mm in length and extended from a position 5 mm distal of the proximal markerband to 8 mm distal of the distal markerband.A visual and tactile examination observed no damage to the tip of the device and no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the gladiator was returned for analysis.A visual examination revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 42 mm in length and extended from a position 5 mm distal of the proximal markerband to 8 mm distal of the distal markerband.A visual and tactile examination observed no damage to the tip of the device and no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that a balloon rupture occurred.A 6.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.A 5f mini-catheter sheath was successfully inserted into the left radial artery, 1 cm proximal to the wrist joint, using the seldinger method.A 6f vascular sheath was then inserted with the 6f guide wire, and 3000u of heparin was administered intravenously.The guide wire was smoothly advanced to the proximal end of the cephalic vein.The 4 x 40mm, 75cm gladiator balloon was delivered and inflated at 24 atm for 30 seconds to treat the occlusion and stenosis in the cephalic vein.However, a follow-up ultrasound revealed insufficient dilation, so a 6 x 40mm, 75cm gladiator balloon was used.During inflation to 20 atm, the pressure dropped, indicating a balloon was broken.A replacement balloon was used, and the pressure was increased to 24 atm for 30 seconds, the occlusion and stenosis of cephalic vein were fully dilated.After withdrawing the catheter and guide wire, the sheath was removed, and local pressure bandaging was applied.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.It was further reported that the stenosis of the lesion was 70% and was located in the mildly tortuous and non-calcified cephalic vein.

• 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: 20904320
• Report Number: 2124215-2024-78273
• Device Sequence Number: 13044823
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: 08714729809739
• 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,Followup
• Report Date (Section B): 01/09/2025

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 Model Number: H74939207060470
• Device Catalogue Number: H74939207060470
• Device Lot Number: 0033274724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 12/12/2024; 12/19/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/08/2025; 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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: Unknown