MAUDE Adverse Event Report: CARDIVA MEDICAL INC. CARDIVA VASCADE 6/7F VCS

Model Number	700-580I
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient injury reported.Conclusion: it appeared that mfg steps were followed, however based on the observed device malfunction, a mfg defect appears to be the cause.
Event or Problem Description
The vascade device was put into sheath and deployed.Temporary hemostasis was achieved and the sheath was removed.The doctor inserted the key into the lock and attempted to pull back the black sleeve, but the sleeve would not retract.At this point the disc was collapsed and the doctor removed the device.It was then observed that the white marker band distal outer sleeve separated from joiner and was removed with the device.It should be noted that the complete device was removed.Manual compression was held to achieve final hemostasis.No injury or complications noted.

• Brand Name: CARDIVA VASCADE 6/7F VCS
• Common Device Name: VASCADE 6/7F
• Manufacturer (Section D): CARDIVA MEDICAL INC.; 2900 lakeside dr.; suite 160; santa clara CA 95054 2812
• MDR Report Key: 5395068
• Report Number: 3004182619-2016-00001
• Device Sequence Number: 18987694
• Product Code: MGB
• UDI-Device Identifier: M729700580I0
• UDI-Public: +M729700580I0/$$7C580I151110AH
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P120016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/26/2016

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: 11/30/2017
• Device Model Number: 700-580I
• Device Catalogue Number: N/A
• Device Lot Number: G580I151110A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 45