MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number IGW0030-15

Device Problems Device Issue (2379); Device Markings/Labelling Problem (2911)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.No conclusion can be drawn at the time of this report.

Event Description

It was reported that the dimension of the product inside the box was perceived as different from the dimension on the labeling.

Manufacturer Narrative

((b)(4)) the involved product has been returned to the manufacturer.Upon inspection, it appears that the graft does not correspond to the labeling text.Indeed, the graft is a knitted graft 20cm length and 12cm diameter (i.E.(b)(4) graft) while the labeling indicates an (b)(4) graft.((b)(4)) a review of the device history records and shipping records indicates that the most probable cause of the mismatch is an error occurring during the manufacturing process.The discrepancy should have been detected during the subsequent control steps.((b)(4)) the capa system has been initiated.The investigation determined that no other product was affected.

• Brand Name: INTERGARD WOVEN GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer (Section G): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• Manufacturer Contact: pascal de framond ; zi athelia 1; la ciotat cedex, 13705 ; FR 13705 ; 3344208779
• MDR Report Key: 4987850
• MDR Text Key: 23908012
• Report Number: 1640201-2015-00030
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K984294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Report Date: 07/20/2015

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: No Information
• Device Expiration Date: 04/30/2020
• Device Model Number: IGW0030-15
• Device Catalogue Number: IGW0030-15
• Device Lot Number: 15E21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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