MAUDE Adverse Event Report: VASCUTEK LTD. GELSEAL; GELSEAL STRAIGHT

Model Number GELSEAL

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

The event was reported to vascutek as follows: incorrect graft was in box.Vascutek contacted site and was informed that the hospital would not return graft.Vascutek inquired what was in the box if not correct graft.Vascutek was informed that graft in box was too short.Vascutek then retrieved a graft from same batch from warehouse stock.On receipt of graft the package was opened and found to contain a 15cm graft rather than the 30cm indicated on the packaging.

Manufacturer Narrative

(b)(4).For a 30cm graft that has been labeled as a 15cm graft, the risk to patient health is negligible as the graft can be cut to size and used without impact on the patient.For a 15 cm graft labeled as a 30cm graft then the impact to patient health could be serious as the potential exists for the graft not be suitable and procedure would be extended.If an alternative graft was not available, then this would further increase the risk to patient.On the basis of this and regulatory reporting requirements, a product recall will be initiated to recall remaining products in the field.

• Brand Name: GELSEAL
• Type of Device: GELSEAL STRAIGHT
• Manufacturer (Section D): VASCUTEK LTD.; newmains ave.; inchinnan business park; renfrewshire, scotland PA4 9RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains ave.; inchinnan business park; renfrewshire, scotland PA4 9RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; 1418125555
• MDR Report Key: 4780707
• MDR Text Key: 19818228
• Report Number: 9612515-2015-00011
• Device Sequence Number: 1
• Product Code: MAL
• Combination Product (y/n): N
• PMA/PMN Number: K955230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: GELSEAL
• Device Catalogue Number: 433008
• Device Lot Number: 301509/02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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): Other