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	08/18/2023
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 target lesion was located in the internal arteriovenous fistula.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1- initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the internal arteriovenous fistula.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon was inflated five times at 10 and 20 atmospheres (atm) respectively.However, during sixth inflation at 20 atm, the balloon ruptured.The device was completely removed by a catheter sheath.
Additional Manufacturer Narrative
Updated b5: describe event or problem.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.A balloon pinhole was identified located approximately 12mm proximal of the proximal markerband.As per gladiator specification the rated burst pressure for this device is 20 atmospheres.A visual examination of the markerbands identified no issues.A visual and tactile examination found the shaft of the device to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual examination identified no damage to the tip.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the internal arteriovenous fistula.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.The device was removed, and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the balloon was inflated five times at 10 and 20 atmospheres (atm) respectively.However, during sixth inflation at 20 atm, the balloon ruptured.The device was completely removed by a catheter sheath.It was further reported that the target lesion was moderately tortuous and severely calcified with 80-90% stenosis.

• 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: 17628878
• Report Number: 2124215-2023-45935
• Device Sequence Number: 7301864
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2023

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: 01/26/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0028720227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2023
• Supplement Date Received by Manufacturer: 08/27/2023; 10/11/2023
• Initial Report FDA Received Date: 08/27/2023
• Supplement Report FDA Received Date: 08/31/2023; 10/18/2023
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 62 KG