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

Model Number	24686
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advance for dilatation.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 status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advance for dilatation.However, during procedure, the balloon was broken.The device was removed, and the procedure was completed with another of same device.There were no patient complication nor injuries reported and the patient was stable following the procedure.It was further reported that the target lesion was moderately tortuous and severely calcified with 70%-80 stenosis.The balloon ruptured during inflation at 20 atmospheres for 40 seconds.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr.: gladiator elite 6.0 x80, 40cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 45mm distal of the proximal balloon bond.From the circumferential tear both the proximal and distal sections of the balloon material were also torn longitudinally along the entire length.No other issues were noted with the balloon material.A visual examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be severely stretched between the distal and proximal balloon bonds.The shaft was also found to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.Both markerbands were present on the shaft of the device.The distal markerband had moved proximally on the shaft most probably due the damage to the shaft.The proximal markerband was damaged but remained in the correct position on the shaft.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advance for dilatation.However, during procedure, the balloon was broken.The device was removed, and the procedure was completed with another of same device.There were no patient complication nor injuries reported and the patient was stable following the procedure.It was further reported that the target lesion was moderately tortuous and severely calcified with 70%-80 stenosis.The balloon ruptured during inflation at 20 atmospheres for 40 seconds.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16748625
• Report Number: 2124215-2023-17784
• Device Sequence Number: 12900552
• Product Code: LIT
• UDI-Device Identifier: 08714729809746
• UDI-Public: 08714729809746
• 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): 05/30/2023

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: 0029458368
• 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: 04/10/2023
• Supplement Date Received by Manufacturer: 04/20/2023; 05/18/2023
• Initial Report FDA Received Date: 04/16/2023
• Supplement Report FDA Received Date: 04/28/2023; 05/30/2023
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 70 KG