FDA Adverse Event Malfunction Summary report: N

FLEXOR RAABE GUIDING SHEATH

MDR report key: 1923315 · Received November 29, 2010

Report

Report Number: 1820334-2010-00604
Event Type: Malfunction
Date Received: November 29, 2010
Date of Event: August 25, 2010
Report Date: November 1, 2010
Manufacturer: COOK, INC.
Product Code: DYB
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

SEPARATES IS NOT SPECIFICALLY ADDRESSED IN THE PROVIDED IFU. ADDITIONAL INFORMATION: PRODUCT HAS NOT YET BEEN RECEIVED TO ASSIST IN THE INVESTIGATION. PER QUALITY CONTROL SPECIFICATION, THERE IS 100% INSPECTION, CONFIRMING THE FLARE ON PROXIMAL END OF SHEATH IS CAUGHT SECURELY IN PROXIMAL FITTINGS AND THAT THE SHEATH DOES NOT ROTATE IN CAP FITTING. IT IS VERIFIED THAT THE COILS IN THE SHEATH CONTINUE INTO CAP. THE FLARES ARE ALSO INSPECTED. IN ADDITION, AN IFU IS PROVIDED THAT INFORMS THE END USER THAT ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. IT IS DIFFICULT TO DETERMINE WITH ANY CERTAINTY WHY THE PHYSICIAN EXPERIENCED THIS FAILURE MODE FOR THIS PRODUCT. INTERIM CORRECTIVE ACTION WAS IMPLEMENTED ON 09/15/2010 (B)(4). THE COMPLAINT DEVICE WAS MANUFACTURED PRIOR TO NOTED CHANGE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED OF THIS COMPLAINT AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS.

Description of Event or Problem · 1

PULLED THE SHEATH BACK AND OVER THE AORTA BIFURCATION TO PUT A WIRE IN AND EXCHANGE FOR A SHORTER SHEATH AND THE HUB CAME CLEAR OFF THE END OF IT. PATIENT OUTCOME WAS REQUESTED BUT NOT PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FLEXOR RAABE GUIDING SHEATH	DYB INTRODUCER, CATHETER	DYB	COOK, INC.	NA	2461934

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK