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 Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an internal fistula with a blood flow rate less than 160 ml per minute.A 7.0 x40, 40 cm gladiator elite balloon catheter was advanced for dilatation.However, during the procedure the balloon failed to dilate the lesion twice, then at 22 atmospheres, it was noted that the pressure pump was pointing at zero.The physician removed the balloon and injected saline into it.The balloon was leaking and noted to be ruptured.The procedure was discontinued.No patient complications were reported and the patient's status was stable.

• Brand Name: GLADIATOR ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8099818
• Report Number: 2134265-2018-63110
• Device Sequence Number: 16611057
• Product Code: LIT
• UDI-Device Identifier: 08714729809784
• UDI-Public: 08714729809784
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2018

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: 05/20/2021
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0022143027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 49