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

Model Number	24686
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in internal arteriovenous fistula.A 4.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon was broken.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in internal arteriovenous fistula.A 4.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon was broken.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable.It was further reported that the target lesion was 60-70% stenosed with a significant bend of >90 degrees, mildly tortuous, and severely calcified.Additionally, balloon rupture occurred instead of the previously reported shaft break as pinhole was noted on the balloon material.
Additional Manufacturer Narrative
(b5) describe event or problem: updated to include new information obtained.(h6) device codes: updated from break to material rupture.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in internal arteriovenous fistula.A 4.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon was broken.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported, and the patient condition was stable.It was further reported that the target lesion was 60-70% stenosed with a significant bend of >90 degrees, mildly tortuous, and severely calcified.Additionally, balloon rupture occurred instead of the previously reported shaft break as pinhole was noted on the balloon material.
Additional Manufacturer Narrative
Device evaluated by mfr.: gladiator elite 4.0 x40, 40cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon partial circumferential tear was identified located approximately 13mm proximal of the distal markerband.As per gladiator specification, the rated burst pressure for this device is 24 atmospheres.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15971599
• Report Number: 2124215-2022-52110
• Device Sequence Number: 6404082
• Product Code: LIT
• UDI-Device Identifier: 08714729809609
• UDI-Public: 08714729809609
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2023

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: 05/23/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029458321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/21/2022; 01/31/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 12/28/2022; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 60 KG