C-QUR MESH

MDR report key: 3282516 · Received August 6, 2013

Report

Report Number: 1219977-2013-00121
Event Type: Injury
Date Received: August 6, 2013
Date of Event: June 9, 2013
Report Date: July 31, 2013
Manufacturer: ATRIUM MEDICAL CORPORATION
Product Code: FTL
PMA / PMN Number: K050311
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT IS UNDER INVESTIGATION AND UPON COMPLETION, A F/U REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

THE DR IMPLANTED THE ORIGINAL SHEET OF C-QUR MESH IN AN OPEN PROCEDURE. WAND COULD NOT GET ADEQUATE PERITONEAL COVERAGE AND NOR RE-APPROXIMATE THE FACIA. DR COULD NOT GET THE MESH TO SIT COMPLETELY FLAT SO USED A TECHNIQUE WHICH INVOLVES SPLITTING THE MESH AND PLEATING IT OVER AND SUTURING IT BACK TOGETHER AS A MEANS OF TIGHTENING IT ONCE IT HAS BEEN FIXATED LATERAL TO THE DEFECT. THE DR HAS BEEN USING C-QUR MESH TO DO SIMILAR PROCEDURES FOR YEARS. THIS TIME HAD TO GO BACK IN ONLY 3 DAYS LATER FOR REASONS THAT NOT MAKE CLEAR. WHEN FIRST SAW THE MESH THE 03FA ADHESION BARRIER REMAINED INTACT. AT SOME POINT DURING THE SECOND PROCEDURE NOTICED THAT A LARGE PORTION OF THE ADHESION BARRIER HAD SIMPLY FALLEN OFF OF THE MESH AND WAS RESTING ON BOWEL. DR THEN REMOVED THE UNCOATED C-QUR MESH AND REPLACED IT WITH A NEW PIECE OF C-QUR MESH. THE DR FELT THE ISSUE MAY HAVE BEEN RELATED TO THE FOLDING OF THE MESH SO TRIED TO KEEP THE SECOND PIECE AS FLAT AS POSSIBLE IN ORDER TO AVOID A SIMILAR RESULT. DR REPORTED THE NEXT PIECE HAS WORKED WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
368900	C-QUR MESH		FTL	ATRIUM MEDICAL CORPORATION	31536	10878121

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other