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

Model Number	24686
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 30nov2023.It was reported that balloon issues occurred.The 75% stenosed target lesion was located in the moderately calcified and moderately tortuous internal arteriovenous fistula.A 5.0x40, 40cm gladiator elite balloon catheter selected for use.However, during preparation, the balloon was found leaking with liquid when it was pressurized, and balloon could not be dilated.A mark of damage was noted in the balloon.The procedure was completed with another balloon catheter.No patient complications were reported, and patient's status was stable.However, device analysis revealed a balloon tear.
Additional Manufacturer Narrative
A2 - age at time of event: the patient is 18 years old or older.Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 2mm proximal of the proximal markerband and extending approximately 44mm distally across the balloon material.With a tear in the balloon material an inflation test could not be carried out.As per gladiator specification the rated burst pressure for this device is 24 atmospheres.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual examination identified no damage to the tip.

• 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: 18373077
• Report Number: 2124215-2023-72443
• Device Sequence Number: 7806024
• Product Code: LIT
• UDI-Device Identifier: 08714729809661
• UDI-Public: 08714729809661
• 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
• Report Date (Section B): 12/21/2023

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: 07/19/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029797563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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: Female
• Patient Weight: 56 KG