MAUDE Adverse Event Report: MAQUET CV 8 MM 40CM HEMASHIELD MDV; GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

Catalog Number VS020953080

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).

Event Description

As done in the past, dr.Alain verdant used an hemashield gold 8mm x 40cm to make a cannulation of the femoral and when under pump, the blood leaked through all the wall of the graft, which did not happen in the past.So the graft was not used as an implant but as a perfusion entry.

Manufacturer Narrative

(b)(4).The graft segment was returned to the factory for evaluation.The entire body of the graft was saturated with blood which had dried into the material of the graft.It is not possible to return the graft to its blood-free state without compromising the integrity of the graft.Due to the returned state of the graft, we are unable to evaluate the graft to confirm the reported complaint because the graft segment was returned in a condition precluding proper evaluation with respect to the reported failure mode ¿leak¿.Therefore, a review of the manufacturing processes was performed.The hemashield gold knitted microvel® double velour vascular graft is impregnated with collagen to improve hemostasis.The device history record (dhr) has been reviewed with special focus on the results of the standard porosity testing performed during final inspection.The records show the device lot conformed to all applicable procedures and specifications.Specifically, the lot passed porosity testing with all permeability values within specification.The test results are available as an attachment to the investigation record.The usage of a graft for temporary bypass represents technically an off-label usage.The blood loss due to the phenomenon described above should not be clinically significant and should not require blood transfusion.

Event Description

As done in the past, dr.(b)(6) used an hemashield gold 8mm x 40cm to make a cannulation of the femoral and when under pump, the blood leaked through all the wall of the graft, which did not happen in the past.So the graft was not used as an implant but as a perfusion entry.

• Brand Name: 8 MM 40CM HEMASHIELD MDV
• Type of Device: GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5329992
• MDR Text Key: 34484206
• Report Number: 2242352-2015-01411
• Device Sequence Number: 1
• Product Code: MAL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: VS020953080
• Device Lot Number: 25106693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other