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

Model Number	H74939207040470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the severely tortuous vessel in the forearm.A 4.0 x40, 75cm gladiator elite was advanced for dilation.However, during first inflation at 24 atmospheres for 60 seconds, the balloon burst.The device was removed, and the procedure was completed with another of the same device.The patient condition following procedure was stable.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: no.(b)(6).
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A partial circumferential tear was identified in the balloon material approximately 12mm proximal from the distal markerband.A visual and tactile examination found no kinks or damage to the shaft and tip of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the severely tortuous vessel in the forearm.A 4.0 x40, 75cm gladiator elite was advanced for dilation.However, during first inflation at 24 atmospheres for 60 seconds, the balloon burst.The device was removed, and the procedure was completed with another of the same device.The patient condition following procedure was stable.

• 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: 20597262
• Report Number: 2124215-2024-68930
• Device Sequence Number: 21068760
• Product Code: LIT
• UDI-Device Identifier: 08714729809616
• UDI-Public: 08714729809616
• 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): 11/26/2024

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 Model Number: H74939207040470
• Device Catalogue Number: H74939207040470
• Device Lot Number: 0033536732
• 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: 10/22/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: Female