FDA Adverse Event Malfunction Summary report: N

BRONCHUS SYSTEM EXTENDED WORKING CHANNEL

MDR report key: 808641 · Received October 19, 2006

Report

Report Number: 3004659744-2006-00002
Event Type: Malfunction
Date Received: October 19, 2006
Date of Event: August 31, 2006
Report Date: September 15, 2006
Manufacturer: SUPERDIMENSION, LTD.
Product Code: KPR
PMA / PMN Number: k042438
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS USER FACILITY SUBMITTED INFORMATION REGARDING TWO EVENTS INVOLVING TWO OF THE COMPANY'S EWC. ONE DEVICE WAS RETURNED FROM THE USER FOR RETURN PRODUCT ANALYSIS, HOWEVER, IT IS UNCLEAR WHETHER THE DEVICE RETURNED IS THE SUBJECT OF THIS MDR REPORT, OR THE SUBJECT OF MDR NO. 3004659744-2006-00003. THE SUPERDIMENSION BRONCHUS SYSTEM INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING WARNING: "WARNING NEVER USE EXCESIVE FORCE (1 KG FORCE (10N)) DURING THE INSERTION OR EXTRACTION OF THE LOCATABLE GUIDE OR ENDOSCOPIC TOOLS THROUGH THE EWC." (PAGE 7-62). INVESTIGATION OF THE RETURNED DEVICE IS ONGOING AND ADDITIONAL INFORMATION WILL BE PROVIDED, IF WARRANTED.

Description of Event or Problem · 1

THE PHYSICIAN NAVIGATED TO A SUSPECTED LESION USING THE BRONCHUS SYSTEM, WITHDREW THE LOCATABLE GUIDE FROM THE EXTENDED WORKING CHANNEL (EWC) AND INSERTED A COMMERCIAL CYTOLOGY BRUSH TO OBTAIN A BIOPSY SAMPLE. ON THE THIRD PASS WITH THE BRUSH, HE OBSERVED UNDER FLUOROSCOPY THAT THE CYTOLOGY BRUSH WAS EXTENDING THROUGH THE SIDE OF THE EXTENDED WORKING CHANNEL. THE BIOPSY SAMPLE HAD BEEN OBTAINED, AND THE PROCEDURE WAS STOPPED. UPON EXAMINATION, A "LONGITUDINAL RIP IN THE SIDE OF THE EWC" WAS OBSERVED. NO PT INJURY OCCURRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BRONCHUS SYSTEM EXTENDED WORKING CHANNEL	GUIDING SHEATH FOR CT X-RAY SYSTEM	KPR	SUPERDIMENSION, LTD.	*	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	*			CYTOLOGY BRUSH\| BRONCHOSCOPE