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	04/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis and received inserted in an introducer sheath, with a guidewire inserted in the device.The introducer sheath was noted to be damaged.The shaft, markerband, and tip underwent a visual and tactile examination.The inner shaft was noted to be stretched.No issues found on the markerbands or tip.The investigator moved the introducer sheath distally to view the balloon, and a full circumferential tear was noted.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was not too stenosed and was non-tortuous and non-calcific.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.This was not used to post-dilate a previously placed stent.During the procedure, on the second inflation, between 15 to 20 atmospheres, the balloon ruptured.The device was successfully retrieved with no fragments left inside the patient and was replaced for a different device to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was not too stenosed and was non-tortuous and non-calcific.A 7.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.This was not used to post-dilate a previously placed stent.During the procedure, on the second inflation, between 15 to 20 atmospheres, the balloon ruptured.The device was successfully retrieved with no fragments left inside the patient and was replaced for a different device to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis and received inserted in an introducer sheath, with a guidewire inserted in the device.The introducer sheath was noted to be damaged.The shaft, markerband, and tip underwent a visual and tactile examination.The inner shaft was noted to be stretched.No issues found on the markerbands or tip.The investigator moved the introducer sheath distally to view the balloon, and a full circumferential tear was noted.

• 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: 19352293
• Report Number: 2124215-2024-30437
• Device Sequence Number: 15274036
• Product Code: LIT
• UDI-Device Identifier: 08714729809784
• UDI-Public: 08714729809784
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 11/07/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030498953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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