FDA Adverse Event Injury Summary report: N

FUSION 8MM-60CM SUPP PERIPHERAL GRAFT

MDR report key: 3812513 · Received May 5, 2014

Report

Report Number: 2242352-2014-00506
Event Type: Injury
Date Received: May 5, 2014
Date of Event: December 12, 2013
Report Date: April 9, 2014
Manufacturer: MAQUET CARDIOVASCULAR, LLC
Product Code: DSY
PMA / PMN Number: K131778
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

Description of Event or Problem · 1

THE HOSPITAL REPORTED A POST-OPERATIVE INFECTION WITH A PATIENT HAVING SURGERY WITH THE FUSION 8MM-60CM SUPP PERIPHERAL GRAFT. IN A SEPARATE SURGERY, THE FUSION 8MM-60CM SUPP PERIPHERAL GRAFT WAS REMOVED FROM THE PATIENT. DATE OF INITIAL SURGERY: (B)(6) 2013. DATE OF REVISION: (B)(6) 2013. DATE THE SURGEON NOTICED INFECTION: (B)(6) 2013. TREATMENT TAKEN FOR THE INFECTION: ADMINISTRATION OF ANTIBIOTICS AND GLOBULIN AND REMOVAL OF THE VASCULAR GRAFT. INFECTING AGENT: STREPTOCOCCUS PYOGENES. IT IS UNKNOWN IF IT IS HUMAN ORIGIN OR NOT. PRIMARY DISEASE: ARTERIOSCLEROSIS OBLITERANS CAUSED BY TOTAL OCCLUSION OF LEFT SUPERFICIAL FEMORAL ARTERY FONTAINE U. PATIENT OUTCOME: INTERMITTENT CLAUDICATION CAUSED BY REMOVAL OF VASCULAR GRAFT. INFECTION WAS CURED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
267875	FUSION 8MM-60CM SUPP PERIPHERAL GRAFT	VASCULAR GRAFT	DSY	MAQUET CARDIOVASCULAR, LLC	M002015030680	25083418

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Other