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

Model Number	24686
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Integrity Problem (2978); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon failure to deflate occurred.The target lesion was located in the left forearm vessel.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, after the device entered the vessel, it could not dilate.When it was removed from the patient's body, it was noted that the balloon was damaged.The procedure was completed using another of the same device.No complications reported, and patient status was stable.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.Device evaluated by mfr.: the device was returned for an analysis and underwent a visual and tactile examination.A leak test identified a balloon pinhole located approximately 3mm distal of the distal markerband.There were no kinks or damages found on the shaft of the device.No issues were noted on the tip and markerbands.
Event or Problem Description
It was reported that balloon failure to deflate occurred.The target lesion was located in the left forearm.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, after the device entered the vessel, it could not dilate.When it was removed from the patient's body, it was noted that the balloon was damaged.The procedure was completed using another of the same device.No complications reported, and patient status was stable.It was further reported that the balloon broke.
Event or Problem Description
It was reported that balloon failure to deflate occurred.The target lesion was located in the left forearm.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, after the device entered the vessel, it could not dilate.When it was removed from the patient's body, it was noted that the balloon was damaged.The procedure was completed using another of the same device.No complications reported, and patient status was stable.It was further reported that the balloon broke.

• 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: 19793265
• Report Number: 2124215-2024-44416
• Device Sequence Number: 4197555
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2024

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: 11/07/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030498907
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 07/18/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 07/25/2024; 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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: 54 KG