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 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.

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.

• 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: 4810737
• MDR Text Key: 5930287
• Report Number: 2020394-2015-00603
• Device Sequence Number: 1
• Product Code: DQR
• 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: 02/28/2018
• Device Catalogue Number: 007714
• Device Lot Number: HUWL1157
• 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
• Date Device Manufactured: 02/01/2013
• 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