MAUDE Adverse Event Report: VASCUTEK GELSOFT

Model Number 680010

Device Problems Material Rupture (1546); Material Perforation (2205)

Patient Problem No Information (3190)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The involved graft was implanted as a bypass between the left axillary artery and the left femoral artery 30 years ago.Examination in 1996 confirmed no issue on the graft.Examination in 2015 found a rupture of the graft and bosselation at the ruptured segment.The rupture was located adjacent to the ribs.The graft was explanted.

Event Description

This report is being submitted as follow up 1 for 9612515-2016-00010 to provide additional information that the device has been returned and the investigation is on-going.

Manufacturer Narrative

Methods codes: actual device evaluated - complaint device was returned to vascutek and evaluated.Visual inspection - visual inspection of the returned graft was completed.Scanning probe microscopy - sem (scanning electron micrographs) analysis was completed.Composition testing - textile analysis was completed.Results codes: mechanical problem - the graft was observed to be punctured in three areas.Friction problem - one end of the graft was flattened.Conclusion codes: operational context caused or contributed to event - the areas of the graft which were observed to be punctured are consistent with user error.The flattened end of the graft indicates that it has been crushed against the ribs when the patient was bending.Unable to confirm complaint.Device not manufactured by reporting firm - the lack of the black line identifier and due to the fact that vascutek were not selling woven grafts to (b)(6) in 1986 would lead to the conclusion this is not a vascutek product.To conclude, the returned product was determined as not being a vascutek device therefore this complaint is invalid and will not be used for tracking and trending purposes going forward.

Event Description

This report is being submitted as follow up #2 for mfr.Report # 9612515-2016-00010 to provide information regarding the returned device evaluation.

• Brand Name: GELSOFT
• Type of Device: GELSOFT
• Manufacturer (Section D): VASCUTEK; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains ave; inchinnan business park; renfrewshire, scotland PA4 9-RR ; UK PA4 9RR ; 418125555
• MDR Report Key: 5430174
• MDR Text Key: 37994597
• Report Number: 9612515-2016-00010
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K02007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2016,04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 680010
• Device Catalogue Number: 680010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: 30 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2016
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR