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	10/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80-90% stenosed target lesion was located in the severely tortuous and severely calcified arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, during eighth inflation for 20 atmospheres for 1 to 3 minutes, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported and the patient's status is stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 80-90% stenosed target lesion was located in the severely tortuous and severely calcified arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, during eighth inflation for 20 atmospheres for 1 to 3 minutes, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported and the patient's status is stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a gladiator device was received for analysis, the following attributes were examined.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was present in the balloon which is indicative of a leak.The rated burst pressure for this device is 20 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 27mm distally of the proximal markerband.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.This concludes the product analysis.

• 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: 15713948
• Report Number: 2124215-2022-44385
• Device Sequence Number: 20483393
• Product Code: LIT
• UDI-Device Identifier: 08714729809838
• UDI-Public: 08714729809838
• 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): 12/02/2022

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: 09/29/2024
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0028113991
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 62 KG