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

Model Number 700-580I

Device Problem Sticking (1597)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pain (1994)

Event Date 12/12/2016

Event Type  Injury  

Manufacturer Narrative

There was no reported device issue.Per the initial report this could have been the result of a high stick.Conclusion: the reported event was not related to device malfunction.Complications such as retroperitoneal bleeding are general complications which may be related to endovascular procedures or vascular closure.

Event Description

The doctor performed a diagnostic coronary cath on the patient and proceeded with his normal routine.At the end of the case, he did a groin shot to view potential to close with vascade.The stick was believed and appeared to be slightly high but no other limitations to be concerned with moving forward.While holding pressure, the patient began to complain of back pain.After holding 10 minutes, hemostasis seemed to be achieved however the patient's symptoms were worsening.The patient became hypotensive and platelet count dropped to a 2.4 in the recovery area.A ct scan was performed and additional pressure was held for about 20 minutes but it was determined that the patient had a retroperitoneal bleed and needed to be rushed to (b)(6).Blood was given as well as fluids.The patient became stable upon arrival at univ hospital.No further intervention was needed.

• Brand Name: CARDIVA MEDICAL VASCADE 6/7F VCS
• Type of Device: VASCADE 6/7F
• Manufacturer (Section D): CARDIVA MEDICAL, INC.; 2900 lakeside drive; suite 160; santa clara CA 95054 2817
• Manufacturer (Section G): CARDIVA MEDICAL, INC.; 2900 lakeside drive; suite 160; santa clara CA 95054 2817
• Manufacturer Contact: robert roland ; 2900 lakeside drive; suite 160; santa clara, CA 95054-2817 ; 4084707131
• MDR Report Key: 6226303
• MDR Text Key: 64020423
• Report Number: 3004182619-2017-00002
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/21/2018
• Device Model Number: 700-580I
• Device Catalogue Number: N/A
• Device Lot Number: G580I161024A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR