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	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the internal arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon burst out.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported and patient condition was stable.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1: initial reporter phone - (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the internal arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon burst out.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported and patient condition was stable.It was further reported that the target lesion was 80-90% stenosed, moderately tortuous and severely calcified.The balloon ruptured on the fifth inflation at 20 atmospheres for 40 to 50 seconds.The device was removed with catheter sheath.
Additional Manufacturer Narrative
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.The rated burst pressure for this device is 24 atmospheres as per gladiator elite specification.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from a balloon pinhole located approximately 2mm proximally of the proximal marker band.A visual examination observed damage to the tip of the device.A visual and tactile examination of the shaft identified no damage.A visual examination found no issues or damage to the markerbands of the device.E1: initial reporter phone - (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the internal arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon burst out.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported and patient condition was stable.It was further reported that the target lesion was 80-90% stenosed, moderately tortuous and severely calcified.The balloon ruptured on the fifth inflation at 20 atmospheres for 40 to 50 seconds.The device was removed with catheter sheath.

• 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: 16724325
• Report Number: 2124215-2023-16921
• Device Sequence Number: 7209493
• 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): 05/23/2023

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: 03/08/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029009411
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 04/18/2023; 05/11/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 04/23/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 65 KG