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	09/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the cephalic vein.A 6.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres the balloon ruptured.The procedure was completed with another of the same balloon catheter.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the cephalic vein.A 6.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres the balloon ruptured.The procedure was completed with another of the same balloon catheter.No patient complications were reported.Device evaluated by mfr.: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.A balloon longitudinal tear was identified, beginning approximately 3mm proximal of the proximal markerband and extending approximately 14mm distally across the balloon material.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this balloon is 24 atmospheres.A visual and microscopic examination found no issues with the markerbands or tip of the device that could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were noted with the device during 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
• MDR Report Key: 7943294
• Report Number: 2134265-2018-61649
• Device Sequence Number: 19067939
• Product Code: LIT
• UDI-Device Identifier: 08714729809753
• UDI-Public: 08714729809753
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/19/2018

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: 05/13/2021
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0022113408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 180CM 0.035 COOK ROADRUNNER; GUIDEWIRE: 180CM 0.035 COOK ROADRUNNER; INFLATOR: MERIT PRESTO; INFLATOR: MERIT PRESTO; SHEATH: 8FR BOSTON SCIENTIFIC SUPER SHEATH; SHEATH: 8FR BOSTON SCIENTIFIC SUPER SHEATH