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

Model Number 24686

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for analysis.A visual examination of the returned device confirmed that the balloon had been subjected to positive pressure.A visual and microscopic examination was performed on the returned gladiator device.A visual and microscopic examination of the returned device identified a longitudinal tear in the balloon material beginning at the distal edge of the proximal markerband, the tear extended distally over the balloon material for approximately 44mm.No issues were noted with the balloon material that could have contributed to the balloon material damage identified.No damage or any issues were noted with the tip of the device.A visual and microscopic examination found no issue with the markerbands which could have contributed to the complaint incident.A visual and tactile examination identified multiple kinks along the length of the device.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft that could have contributed to the damage identified.No other issues were noted with the device.

Event Description

Reportable based on device analysis completed on (b)(6) 2019.It was reported that crossing difficulties were encountered.A 7.0x40, 75cm gladiator elite balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed a longitudinal balloon tear.

• Brand Name: GLADIATOR ELITE
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8387025
• MDR Text Key: 137717303
• Report Number: 2134265-2019-01967
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: 08714729809791
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0021687804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 52