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	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified venous anastomosis.A 8.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during initial inflation at 18 atmospheres, the balloon ruptured.The device was aspirated and removed.The procedure was completed successfully with another 8x80 gladiator device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified venous anastomosis.A 8.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during initial inflation at 18 atmospheres, the balloon ruptured.The device was aspirated and removed.The procedure was completed successfully with another 8x80 gladiator device.There were no patient complications reported.It was further reported that the balloon was inflated for 30 seconds.
Additional Manufacturer Narrative
D4: lot number: corrected from 28872901 to 28764143 d4: expiration date: corrected from 02/14/2025 to 01/27/2025 h4: device manufacture date: corrected from 02/15/2022 to 01/28/2022.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified venous anastomosis.A 8.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during initial inflation at 18 atmospheres, the balloon ruptured.The device was aspirated and removed.The procedure was completed successfully with another 8x80 gladiator device.There were no patient complications reported.It was further reported that the balloon was inflated for 30 seconds.
Additional Manufacturer Narrative
D4: lot number: corrected from 28872901 to 28764143.D4: expiration date: corrected from 02/14/2025 to 01/27/2025.H4: device manufacture date: corrected from 02/15/2022 to 01/28/2022.Device evaluated by mfr.: a gladiator device was returned 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 20 atm 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 25mm distally of the proximal marker band.An examination of the balloon material and proximal marker band identified no issues which could potentially have contributed to this complaint.A visual examination observed no damage to the tip of the device.A visual and tactile examination of the shaft of the device found no issues.A visual examination found no issues or damage to the markerbands of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified venous anastomosis.A 8.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during initial inflation at 18 atmospheres, the balloon ruptured.The device was aspirated and removed.The procedure was completed successfully with another 8x80 gladiator device.There were no patient complications reported.It was further reported that the balloon was inflated for 30 seconds.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15357706
• Report Number: 2124215-2022-34084
• Device Sequence Number: 1622752
• Product Code: LIT
• UDI-Device Identifier: 08714729809913
• UDI-Public: 08714729809913
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup
• Report Date (Section B): 10/07/2022

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: 01/27/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0028764143
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 09/02/2022; 09/21/2022; 10/06/2022
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 09/07/2022; 09/27/2022; 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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: 76 YR
• Patient Sex: Female
• Patient Race: Black Or African American