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	08/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: (b)(6).D4: lot number: updated to 0029642295.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified forearm artery.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, during the first inflation at 20 atmospheres for 30 seconds, the balloon ruptured.The device was removed during open heart procedure and the procedure was completed with another of the same device.There were no patient complications reported and patient condition was stable.
Event or Problem Description
It was reported that balloon rupture and a surgical intervention occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified forearm artery.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, during the first inflation at 20 atmospheres for 30 seconds, the balloon ruptured.The device was removed with an open-heart procedure and the procedure was completed with another of the same device.The patient condition was stable.It was further reported that, the physician performed an open fistula reconstruction procedure on the patient.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).D4: lot number: updated to 0029642295.Device evaluated by mfr.Gladiator 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 partial balloon circumferential tear was identified located approximately 13mm distal of the proximal markerband.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.

• 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: 17748761
• Report Number: 2124215-2023-47571
• Device Sequence Number: 4236228
• Product Code: LIT
• UDI-Device Identifier: 08714729809616
• UDI-Public: 08714729809616
• 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,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 0029642295
• 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: 08/27/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 75 KG