MAUDE Adverse Event Report: CONCENTRIC MEDICAL FLOWGATE2 8F X 85CM; CATHETER, PERCUTANEOUS

Catalog Number 90485

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during a carotid artery stenting procedure, the subject balloon leakage and pinholes were observed.No other information was provided.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the coil contributing to the reported damages.Therefore, an assignable cause of procedural factor has been assigned to this investigation.

Event Description

It was reported that during a carotid artery stenting procedure, the subject balloon leakage and pinholes were observed.No other information was provided.

• Brand Name: FLOWGATE2 8F X 85CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 7640063
• MDR Text Key: 112442745
• Report Number: 0002954917-2018-00056
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00815742004854
• UDI-Public: 00815742004854
• Combination Product (y/n): N
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: 90485
• Device Lot Number: 62141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE 14 (ASAHI CHIKAI).