MAUDE Adverse Event Report: VASCUTEK LTD. GELSOFT; GELSOFT FEM-FEM ERS CENTRAL R/FORCED

Model Number GELSOFT

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problems Occlusion (1984); Peripheral Vascular Disease (2002)

Event Date 12/02/2014

Event Type  Injury  

Event Description

The event was reported to vascutek ltd.As follows: the graft occluded on the same day that it was implanted.The graft was explanted and replaced with a heparinised graft (of unknown manufacture and type).

Manufacturer Narrative

On the same day of implant, the device was explanted due to occlusion patient has condition pvd or pad.Coagulation in device or device ingredient.Method: actual device not evaluated - evaluation is currently in progress but not yet completed.A review of the retained manufacturing and quality records indicated that the device and its associated batch were manufactured to specifications.The review of the records indicated that all processes were completed as per specifications.Results: results pending completion of evaluation.A review of the quality and manufacturing records confirmed that the graft and its associated batch were manufactured to specifications.Conclusion: vascutek are unable to draw any definitive conclusions regarding the root cause of this event at this stage, as the evaluation of the device is pending completion.

• Brand Name: GELSOFT
• Type of Device: GELSOFT FEM-FEM ERS CENTRAL R/FORCED
• Manufacturer (Section D): VASCUTEK LTD.; newmains ave.; inchinnan business park; renfrewshire, scotland PA4 9RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains ave.; inchinnan business park; renfrewshire, scotland PA4 9-RR ; UK PA4 9RR ; 1418125555
• MDR Report Key: 4407105
• MDR Text Key: 5309472
• Report Number: 9612515-2015-00002
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2014,01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: GELSOFT
• Device Catalogue Number: 673006
• Device Lot Number: 300730/06
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/02/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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
• Patient Outcome(s): Required Intervention