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

Catalog Number	90073
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
[medwatch mw5077097.Pdf].Device not returned.
Event or Problem Description
Medwatch report (mw5077097) was received from the fda on june 21, 2018.It was reported that after the thrombectomy procedure, the balloon catheter could not be deflated.The balloon catheter eventually was deflated enough to be removed from the patient¿s anatomy and the procedure was completed.No clinical consequences to the patient reported.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.The information provided in the complaint indicated that no damage was noted to the device, the device was in good condition after unpacking/preparation, the device was prepared as per the direction for use (dfu) and continuous flush was maintained.While there are several potential causes for the reported issue, since the review and analysis of the available information failed to identify a definitive cause and because the product was not returned for analysis, an assignable cause of undetermined was assigned to the as reported issue ' nv balloon difficult/unable to deflate'.
Event or Problem Description
Medwatch report (mw(b)(4)) was received from the fda on june 21, 2018.It was reported that after the thrombectomy procedure, the balloon catheter could not be deflated.The balloon catheter eventually was deflated enough to be removed from the patient¿s anatomy and the procedure was completed.No clinical consequences to the patient reported.

• Brand Name: 8F BGC 95CM
• Common Device Name: CATHETER, PERCUTEANEOUS
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 7701816
• Report Number: 0002954917-2018-00059
• Device Sequence Number: 16476156
• Product Code: DQY
• UDI-Device Identifier: 00815742000733
• UDI-Public: 00815742000733
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K112404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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: 08/28/2018
• Device Catalogue Number: 90073
• Device Lot Number: 60811
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1