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

Model Number	24686
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and detachment occurred and was difficult to remove which require additional intervention.The 80% stenosed target lesion was located in the mild calcified left anterior descending.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, under ultrasound it was found that balloon was retracted and was determined that the balloon was ruptured upon ninth inflation at 18 atmospheres for 30 to 60 seconds.There was a resistance when the balloon was removed with the puncture sheath, upon removal a horizontal fractured was noted with the balloon and the remaining fragment could not be pulled out.The skin was cut along the catheter placement, and the blood vessel was dissectioned.The blood vessel was cut vertically for about 5mm, the fragment was seen.Vascular anastomosis was performed after removing the detached fragment with blood vessel forceps.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Event or Problem Description
It was reported that balloon rupture and detachment occurred and was difficult to remove which require additional intervention.The 80% stenosed target lesion was located in the mild calcified left anterior descending.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, under ultrasound it was found that balloon was retracted and was determined that the balloon was ruptured upon ninth inflation at 18 atmospheres for 30 to 60 seconds.There was a resistance when the balloon was removed with the puncture sheath, upon removal a horizontal fractured was noted with the balloon and the remaining fragment could not be pulled out.The skin was cut along the catheter placement, and the blood vessel was dissectioned.The blood vessel was cut vertically for about 5mm, the fragment was seen.Vascular anastomosis was performed after removing the detached fragment with blood vessel forceps.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.It was further reported that the target lesion was located in the blood vessel of left forearm.

• 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: 19773485
• Report Number: 2124215-2024-43192
• Device Sequence Number: 18171511
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: 08714729809791
• 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): 09/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2026
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0032142578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 08/11/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 08/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 61 KG