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	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the arteriovenous fistula.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon burst.The procedure was completed with another of same device.There were no patient complications nor injuries reported, and the patient status was stable.
Additional Manufacturer Narrative
B5: describe event or problem: updated.E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the arteriovenous fistula.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon burst.The procedure was completed with another of same device.There were no patient complications nor injuries reported, and the patient status was stable.It was further reported that the 70% stenosed target lesion was located in the unknown tortuosity and non-calcified arteriovenous fistula.The device ruptured at 24 atmospheres for 30 seconds.The device was recovered to the sheath and was removed.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the arteriovenous fistula.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon burst.The procedure was completed with another of same device.There were no patient complications nor injuries reported, and the patient status was stable.It was further reported that the 70% stenosed target lesion was located in the unknown tortuosity and non-calcified arteriovenous fistula.The device ruptured at 24 atmospheres for 30 seconds.The device was recovered to the sheath and was removed.
Additional Manufacturer Narrative
B5: describe event or problem: updated e1 initial reporter phone:(b)(6).Device evaluated by mfr.: gladiator elite 8.0 x40, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 20 atmospheres for 30 seconds using digital timer without issue.A vacuum was then applied.The inflation device was verified at 20 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure of 20 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per gladiator specification the rated burst pressure for this device is 20 atmospheres.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.

• 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: 17783239
• Report Number: 2124215-2023-51399
• Device Sequence Number: 5492561
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: 08714729809876
• 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,Followup
• Report Date (Section B): 10/31/2023

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: 08/02/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029881052
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 10/20/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 09/29/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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 Sex: Unknown