MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC EXXCEL SOFT THIN WALL STR EXT S 8/70/70; VASCULAR GRAFT

Model Number VS004930780

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

The hospital reported that when they removed the graft from the shelf it was observed that the wrong label was in one of the exxcel soft thin wall str ext s 8/70/70.The outer package was labeled as 8mm, but the inner package was labeled as 6mm graft (4930760 - lot# 25081311).There was no pt involvement.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the eval is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.There are no other similar complaints reported against this batch.(b)(4).

• Brand Name: EXXCEL SOFT THIN WALL STR EXT S 8/70/70
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097690
• MDR Report Key: 4138693
• MDR Text Key: 4798184
• Report Number: 2242352-2014-01042
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K962433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: VS004930780
• Device Catalogue Number: M002004930780
• Device Lot Number: 25080771
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• 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