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

Model Number 24686

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: gladiator elite device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was observed in the balloon body indicating presence of a leak.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at approximately 12 mm from the proximal end of the proximal markerband.The rated burst pressure for this device is 14 atmospheres.A visual and microscopic examination observed no issues with the tip of the device which could potentially 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 Description

Reportable based on device analysis completed on 06-nov-2019.It was reported that balloon leak occurred.The target lesion was located in a cephalic arch vein.A 10.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon contrast leaked out of the distal part of the balloon.They immediately removed the balloon for inspection.Once outside of the body, the balloon was put in the saline bowl and inflated and was noted that the balloon was leaking contrast from the distal portion.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed a balloon pinhole.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9378362
• MDR Text Key: 173776549
• Report Number: 2134265-2019-14068
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729809517
• UDI-Public: 08714729809517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0024091506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2019
• 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