MAUDE Adverse Event Report: VASCUTEK LTD. GELWEAVE; GELWEAVE 4 BRANCH PLEXUS

Model Number GELWEAVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems High Blood Pressure/ Hypertension (1908); Aortic Dissection (2491)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

The event was reported to vascutek as follows: blood leakage on body below branch.Blood oozing slowly.

Manufacturer Narrative

Vascutek has requested representative contact surgeons several times for further information; however, they have been unsuccessful in obtaining any further details regarding this case therefore vascutek does not expect to receive any further information.No further actions required however, the issue will be tracked and trended as part of the routine complaints monitoring and reporting process.If an adverse trend develops action may be taken at that time.Vascutek now considers this complaint closed.

• Brand Name: GELWEAVE
• Type of Device: GELWEAVE 4 BRANCH PLEXUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains ave.; inchinnan business park; inchinnan, renfrewshire PA4 9RR; UK PA4 9RR
• Manufacturer Contact: carolyn forrest ; newmains ave.; inchinnan, renfrewshire PA4 9-RR ; UK PA4 9RR ; 418125555
• MDR Report Key: 4894454
• MDR Text Key: 18266126
• Report Number: 9612515-2015-00016
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K040829
• 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: 06/05/2015,07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: GELWEAVE
• Device Catalogue Number: 73281088/10
• Device Lot Number: 353594/01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2015
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 06/05/2015
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 81