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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x20, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during second inflation at 24 atmospheres, the balloon ruptured.The procedure was completed with the original device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a gladiator 6 x 20,24atm,75cm 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 longitudinal tear was identified in the balloon material.The tear measured 32mm in length and extended from a position 6mm proximal of the proximal markerband to 5mm distal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on 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.A 6.0 x20, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during second inflation at 24 atmospheres, the balloon ruptured.The procedure was completed with the original device.There were no patient complications nor injuries reported.

• 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: 11186926
• Report Number: 2134265-2021-00427
• Device Sequence Number: 19632828
• Product Code: LIT
• UDI-Device Identifier: 08714729809715
• UDI-Public: 08714729809715
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2021

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: 06/23/2023
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0025628525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/06/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 02/23/2021
• 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: GUIDEWIRE USED: 180CM LAUREATE MERIT; GUIDEWIRE USED: 180CM LAUREATE MERIT; INFLATOR USED: MERIT PRESTO; INFLATOR USED: MERIT PRESTO; INTRODUCER SHEATH USED: 6FR BS SUPER SHEATH; INTRODUCER SHEATH USED: 6FR BS SUPER SHEATH