FDA Adverse Event Injury Summary report: N

HEMASHIELD PLATINUM VASCULAR GRAFT

MDR report key: 1980392 · Received February 3, 2011

Report

Report Number: 2242352-2011-00001
Event Type: Injury
Date Received: February 3, 2011
Date of Event: December 20, 2010
Report Date: January 4, 2011
Manufacturer: MAQUET CARDIOVASCULAR, LLC
Product Code: DSY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

BEING INVESTIGATED. THE DEVICE REMAINS IMPLANTED AND IS, THEREFORE, NOT AVAILABLE FOR A TECHNICAL EVALUATION. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AS REQUIRED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH APPLICABLE QUALITY PROCEDURES. THE STERILITY RECORDS WERE REVIEWED AND REVEALED THAT THIS DEVICE WAS STERILIZED WITHIN THE DOSE RANGE THAT IS SPECIFIED IN INTERNAL STERILIZATION PROCEDURES. THE PRODUCTION BATCH RECORD FOR THIS PRODUCT SHOWS THAT IT WAS RELEASED IN ACCORDANCE WITH ALL GOVERNING QUALITY ASSURANCE/QUALITY CONTROL PROCEDURES PRIOR TO DISTRIBUTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THIS BATCH. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT AFTER SURGERY WITH A HEMASHIELD GRAFT AND A VALSALVA GRAFT BEING IMPLANTED AT THE SAME TIME, THE PATIENT WAS INFECTED BY A BACTERIAL VIRUS, PSEUDOMONAS. THE INITIAL PROCEDURE TOOK PLACE ON (B)(6) 2010. THE PATIENT RETURNED FOR A SECOND PROCEDURE ON (B)(6) 2010 TO REMOVE PUS DUE TO THE INFECTION. THE PATIENT THEN RETURNED FOR A THIRD PROCEDURE ON (B)(6) 2010, TO AGAIN REMOVE PUS, EVEN FROM THE BONE. IT WAS REPORTED THAT THE PATIENT WAS IN THE ICU WITH BLOOD POISONING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HEMASHIELD PLATINUM VASCULAR GRAFT	VASCULAR GRAFT	DSY	MAQUET CARDIOVASCULAR, LLC	175828P	25007526

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Other