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	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - used (b)(6) 2019 since reported event date was from week of (b)(6) 2019.
Event or Problem Description
It was reported that balloon rupture occured.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, upon inflation, it was noted that there was a small leak at the distal portion of the balloon.After removing the device, a visible pinhole on the balloon was noted.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event - used (b)(6) 2019 since reported event date was from week of (b)(6) 2019.Device evaluated by mfr.: gladiator elite 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.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at approximately 8 mm proximal of the proximal end of the proximal markerband.The rated burst pressure for this device is 20 atmospheres.A visual and microscopic examination observed no issues with the tip of the device which could potentially 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 identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occured.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, upon inflation, it was noted that there was a small leak at the distal portion of the balloon.After removing the device, a visible pinhole on the balloon was noted.The procedure was completed with a different device.No patient complications were reported.It was further reported that during inflation at 10-12 atmospheres, a leak was noted on fluoroscopy and the balloon was unable to hold pressure.

• 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: 8911708
• Report Number: 2134265-2019-09237
• Device Sequence Number: 1606782
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: 08714729809791
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/20/2019

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: 06/08/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0023923124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1