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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. JAVID CAROTID BYPASS SHUNT

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BARD PERIPHERAL VASCULAR, INC. JAVID CAROTID BYPASS SHUNT Back to Search Results
Catalog Number 007714
Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
A manufacturing review was conducted. Lot met all release criteria. The complaint investigation is inconclusive as the sample was not returned for evaluation. Based on the available information, the definitive root cause is unknown. Section a through d: the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that a carotid bypass shunt was smaller then the specified dimensions of the shunt; therefore, the carotid bypass shunt was exchanged for a new bypass shunt. There is no reported patient contact. There is no reported patient injury.
 
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Brand NameJAVID CAROTID BYPASS SHUNT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ
Manufacturer (Section G)
BARD SHANNON LIMITED
lot #1, road #3, km 79.7
san geronimo industrial park
humacao PR 00791
Manufacturer Contact
bryan vogel
1625 west 3rd st
tempe, AZ 85281
4808949515
MDR Report Key4810737
MDR Text Key13408992
Report Number2020394-2015-00603
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/12/2013
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue Number007714
Device Lot NumberHUWL1157
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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