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	03/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient had iliac venous compression syndrome.Vascular access was gained via the left iliac femoral vein through the left anterior tibial veins.The target lesion was located in the iliac vein.A 8.0 x80, 75cm gladiator balloon catheter was advanced for dilatation; however, during inflation at 8 atmospheres (atm).The balloon ruptured and blood flowed back to the pump.So, a 10.0 x80, 75cm charger balloon catheter was advanced for dilatation; however, during inflation at 9 atm, the balloon ruptured.The procedure was completed with another 10.0 x80, 75cm charger balloon catheter.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The patient had iliac venous compression syndrome.Vascular access was gained via the left iliac femoral vein through the left anterior tibial veins.The target lesion was located in the iliac vein.A 8.0 x80, 75cm gladiator balloon catheter was advanced for dilatation; however, during inflation at 8 atmospheres (atm).The balloon ruptured and blood flowed back to the pump.So, a 10.0 x80, 75cm charger balloon catheter was advanced for dilatation; however, during inflation at 9 atm, the balloon ruptured.The procedure was completed with another 10.0 x80, 75cm charger balloon catheter.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a gladiator device - 8x80x27 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 an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 35mm 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 as per gladiator specification.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No issues were identified during the product 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: 9868248
• Report Number: 2134265-2020-03720
• Device Sequence Number: 13570288
• Product Code: LIT
• UDI-Device Identifier: 08714729809913
• UDI-Public: 08714729809913
• 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): 05/14/2020

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: 09/04/2021
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0022612096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR