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	05/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occured.The target lesion was located in the iliac vein.A 10.0 x 80, 75 cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, it was noted that the balloon was broken before it reached the bursting pressure.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and patient's status was stable.
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.A visual examination identified no tears in the balloon.The device was attached to an encore inflation unit and during an attempt to inflate the balloon a pinhole leak was identified at the proximal edge of the distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.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 multiple kinks at various locations along the shaft.These kinks are consistent with excessive force having been applied to the shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occured.The target lesion was located in the iliac vein.A 10.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, during the procedure, it was noted that the balloon was broken before it reached the bursting pressure.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and 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: 8735698
• Report Number: 2134265-2019-06669
• Device Sequence Number: 16616799
• Product Code: LIT
• UDI-Device Identifier: 08714729826415
• UDI-Public: 08714729826415
• 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,Followup
• Report Date (Section B): 07/19/2019

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: 03/28/2021
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0021930241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 71