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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCUTEK LTD GELWEAVE; GELWEAVE COSELLI THORACOABDOMINAL 4 BRANCH
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VASCUTEK LTD GELWEAVE; GELWEAVE COSELLI THORACOABDOMINAL 4 BRANCH Back to Search Results
Model Number GELWEAVE
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/29/2018
Type of Reportable Event Malfunction
Event or Problem Description
On (b)(6) 2018, the patient underwent a procedure to have a gelweave coselli thoracoabdominal graft implanted.During the procedure, the clinician reported that the right renal branch root was leaking.Protamine was applied to arrest the leak, which was unsuccessful.The clinician then applied a suture to the affected area and completed the procedure without any further incident.
 
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Brand Name
GELWEAVE
Common Device Name
GELWEAVE COSELLI THORACOABDOMINAL 4 BRANCH
Manufacturer (Section D)
VASCUTEK LTD
newmains avenue
inchinnan business park
renfrewshire PA4 9 RR
UK  PA4 9RR
MDR Report Key7905082
Report Number9612515-2018-00013
Device Sequence Number19200803
Product Code DSY
UDI-Device Identifier05037881107233
UDI-Public05037881107233
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K090987
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/25/2018
Report Date (Section F) 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/30/2023
Device Model NumberGELWEAVE
Device Catalogue Number732410108/8S4
Device Lot Number17292242
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/29/2018
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer08/29/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/29/2018
Initial Report FDA Received Date09/25/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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