FDA Adverse Event Injury Summary report: N

FIBERED IDC OCCLUSION SYSTEM

MDR report key: 1954900 · Received January 10, 2011

Report

Report Number: 2134265-2010-05982
Event Type: Injury
Date Received: January 10, 2011
Date of Event: December 17, 2010
Report Date: December 17, 2010
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: KRD
PMA / PMN Number: K060078
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A EMBOLIZATION TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED. THE PATIENT PRESENTED FOR A VARICOSE SEAL EMBOLIZATION. THE 6MM X 20CM FIBERED IDC OCCLUSION SYSTEM WAS ADVANCED AND DURING THE COIL DEPLOYMENT THE INTERLOCK COIL BECAME STUCK IN A .027 NON-BSC MICROCATHETER. HOWEVER, WITH ADDITIONAL MANEUVERING OF THE COIL PUSHER THE COIL WAS SUCCESSFULLY DEPLOYED. AS A RESULT, A SMALL DISSECTION OCCURRED WITHIN THE VESSEL. THE DISSECTION WAS TREATED WITH ADDITIONAL DEPLOYMENT OF NON-BSC COILS. THE PROCEDURE OUTCOME IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FIBERED IDC OCCLUSION SYSTEM	DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION	KRD	BOSTON SCIENTIFIC - CORK	M001361570	13491124

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	MICROCATHETER, TERUMO .027 PROGREAT