MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY GLADIATOR¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939207120470

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the 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 identified within the balloon and inflation lumen which is evidence of a device leak.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 13mm proximal to the proximal end of the proximal marker band.No issues were identified with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination found no issues with the markerbands or tip of the device that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft of the device that could have contributed to the complaint incident.No other issues were noted with the device during analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon had a pinhole.The target lesion was located in a vessel in the left arm.A 12.0 x40 75cm gladiator¿ balloon catheter was advanced for dilation.However, contrast leakage was observed from the beginning of the initial inflation and there was a hole noted on the balloon.The device was easily removed from the patient's body and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.

• Brand Name: GLADIATOR¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7385395
• MDR Text Key: 104036374
• Report Number: 2134265-2018-02446
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113681
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Model Number: H74939207120470
• Device Catalogue Number: 3920712047
• Device Lot Number: 21494168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• 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