MAUDE Adverse Event Report: CONCENTRIC MEDICAL 8F BGC 95CM; CATHETER, PERCUTANEOUS

Catalog Number	90073
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported the balloon failed to inflate during preparation and a leak was noted.There was no clinical consequence to the patient as a result of this event.
Additional 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 neither physical nor functional evaluation could be performed.Based on the information currently available an assignable cause for this event cannot be determined.
Event or Problem Description
It was reported the balloon failed to inflate during preparation and a leak was noted.There was no clinical consequence to the patient as a result of this event.

• Brand Name: 8F BGC 95CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 7501441
• Report Number: 0002954917-2018-00046
• Device Sequence Number: 1124528
• Product Code: DQY
• UDI-Device Identifier: 00815742000733
• UDI-Public: (01)00815742000733(17)180728(10)60494
• Combination Product (Y/N): N
• PMA/510(K) Number: K112404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: 90073
• Device Lot Number: 60494
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR