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

Model Number	24686
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: gladiator elite 7.0 x80, 75cm was received for analysis.The following attributes were examined: a visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 3mm proximal of the proximal markerband and extending approximately 31mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 20 atmospheres as per gladiator specification.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination identified no issues or damage to the tip of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable.It was further reported that the target lesion was 80% stenosed, severely calcified, and severely tortuous.
Additional Manufacturer Narrative
Device evaluated by mfr: gladiator elite 7.0 x80, 75cm was received for analysis.The following attributes were examined: a visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 3mm proximal of the proximal markerband and extending approximately 31mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 20 atmospheres as per gladiator specification.A visual examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination identified no issues or damage to the tip of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, the balloon ruptured.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

• 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: 15509425
• Report Number: 2124215-2022-38624
• Device Sequence Number: 17652564
• Product Code: LIT
• UDI-Device Identifier: 08714729809838
• UDI-Public: 08714729809838
• 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): 11/10/2022

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: 01/26/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0028720221
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 11/03/2022; 11/07/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/08/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 78 KG