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	09/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a left arteriovenous fistula.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The device was replaced with another 8.0 x40, 75cm gladiator elite balloon catheter; however, during inflation at 18 atmospheres, the balloon ruptured and the balloon parts came off.The broken fragments were completely removed from the patient's body with a snare.The procedure was completed with a non-bsc device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was return for analysis.A visual examination identified a longitudinal tear in the returned balloon material 5mm proximal of the tip of the device.The longitudinal tear is jagged and is approximal 27mm in length.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the damage identified.The rate of burst pressure of this device is 20 atmospheres.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.No damage or any issues were noted with the polymer extrusion shaft that could have contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a left arteriovenous fistula.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The device was replaced with another 8.0 x40, 75cm gladiator elite balloon catheter; however, during inflation at 18 atmospheres, the balloon ruptured and the balloon parts came off.The broken fragments were completely removed from the patient's body with a snare.The procedure was completed with a non-bsc device.No patient complications were reported and the patient's status was fine.It was further reported that there was a greater than 90% stenosis, with non-calcified target lesion.

• 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: 9152992
• Report Number: 2134265-2019-11631
• Device Sequence Number: 11544076
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: 08714729809791
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K132810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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: 02/07/2020
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0020259799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1