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	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in left upper extremity.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the fifth inflation at 18 atmospheres for 15 seconds, the balloon ruptured.The device was removed in normal way through the sheath, and no detached segment was left inside the patient's body.The procedure was completed with another of the same device.There were no patient complications reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in left upper extremity.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.However, during the fifth inflation at 18 atmospheres for 15 seconds, the balloon ruptured.The device was removed in normal way through the sheath, and no detached segment was left inside the patient's body.The procedure was completed with another of the same device.There were no patient complications reported, and the patient was stable post-procedure.
Additional Manufacturer Narrative
E1 (b)(6).Device evaluated by mfr.: a gladiator device 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 longitudinal tear was identified in the balloon material.The tear measured 45 mm in length and extended from a position 5mm proximal of the proximal markerband to 4mm distal of the distal markerband.A visual examination of the tip identified damage.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.

• 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 wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17017138
• Report Number: 2124215-2023-25781
• Device Sequence Number: 7168121
• Product Code: LIT
• UDI-Device Identifier: 08714729809722
• UDI-Public: 08714729809722
• 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
• Report Date (Section B): 06/22/2023

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: 06/22/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029642758
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 05/29/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2022
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 70 KG