MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24686
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
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 7.0x60, 75cm gladiator elite balloon catheter was advanced for intra-stent dilatation.However, during third inflation, the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the cephalic vein.A 7.0x60, 75cm gladiator elite balloon catheter was advanced for intra-stent dilatation.However, during third inflation, the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the 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.Blood was identified within the balloon which is evidence of a device leak.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 9mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 20 atmospheres.A visual and microscopic examination found no issues with the markerbands.The tip of the device was noted to be severely flared.This type of damage is consistent with excess force being applied to the device as a result of meeting resistance during the attempt to cross a lesion.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: 8476137
• Report Number: 2134265-2019-03354
• Device Sequence Number: 13821509
• Product Code: LIT
• UDI-Device Identifier: 08714729809814
• UDI-Public: 08714729809814
• 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): 04/30/2019

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: 12/12/2021
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0023077685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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: INFLATION DEVICE: MERIT BASIX; INFLATION DEVICE: MERIT BASIX