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

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  

Event Description

It was reported that a carotid bypass shunt was smaller than 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.

Manufacturer Narrative

A further clinical review of this event was performed and identified the event to be mdr reportable pursuant to 21 cfr part 803.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.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.

• Brand Name: JAVID 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 Key: 4810764
• MDR Text Key: 5920121
• Report Number: 2020394-2015-00678
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 007714
• Device Lot Number: HUWF556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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