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	02/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, upon inflation at 6 atmospheres for 10 seconds, the balloon ruptured.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with another of the same device.No patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device manufacture date: updated to 07/24/2018.Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device confirmed that the balloon was unfolded had been subjected to positive pressure.A visual and microscopic examination was performed on the returned gladiator device.The returned device was attached to an encore inflation unit and positive pressure was applied when a pinhole leak was identified in the balloon material approximately 11mm proximal to the proximal edge of the proximal markerband.A visual and microscopic examination of the balloon identified no issues with the balloon material that have contributed to the damage identified.A visual and microscopic examination found no issue with the markerbands of the device which could have contributed to the complaint incident.A visual and microscopic examination identified no issues with the tip 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 identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.However, upon inflation at 6 atmospheres for 10 seconds, the balloon ruptured.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with another of the same device.No patient complications reported and the 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: 8441853
• Report Number: 2134265-2019-02836
• Device Sequence Number: 2639643
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 07/23/2021
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0022416469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 05/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 75