MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24686
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and removal difficulties were encountered.The target lesion was located in a vessel in the abdomen.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation at 18 atmospheres, the balloon ruptured.The balloon could not be withdrawn so the physician then cut the delivery system and removed the balloon by surgical incision.The procedure was completed with another of same device.There were no further 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: 12026272
• Report Number: 2134265-2021-07699
• Device Sequence Number: 13796714
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: 08714729809678
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2022
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024297837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 65