FDA Adverse Event Malfunction Summary report: N

MERCI RETRIEVER X6

MDR report key: 616151 · Received June 2, 2005

Report

Report Number
2954917-2005-00008
Event Type
Malfunction
Date Received
June 2, 2005
Date of Event
May 12, 2005
Report Date
June 2, 2005
Manufacturer
CONCENTRIC MEDICAL, INC.
Product Code
NRY
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE PHYSICIAN WAS TREATINE A PATIENT WITH A COMPLETE OCCLUSION OF THE PROXIMAL M 1 SEGMENT. ON THE THIRD PASS USING THE RETIEVER , THE PHYSICIAN FOLLOWED THE RECOMMENDED TORQUE TECHNIQUES BUT DID NOT REPOSITION THE MICROCATHETER PROXIMAL TO THE PROXIMAL LOOPS BEFORE APPLYING TORQUE. THE RETRIEVER STRETCHED DURING WITHDRAWAL AND THE PHYSICIAN RELAXED THE SYSTEM ALLOWING THE HELIX TO RESHAPE. UPON DEVICE WITHDRAWAL, HE NOTICED A SEPARATION (FRACTURE)ON COREWIRE PROXIMAL TO THE RETRIEVER HELIX. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FRACTURED TIP. THE FIRST ATTEMPT WAS MADE USING A 4MM MICROVENA SNARE, THE SECOND ATTEMPT WAS MADE USING A MERCI RETRIEVER X5 - BOTH ATTEMPTS WERE UNSUCCESSFUL. THE THIRD ATTEMPT, USING A 4MM MICROVENA SNARE, SUCCESSFULLY RETRIEVED THE FRACTURED TIP. THERE WERE NO REPORTED DEVICE RELATED SIGNIFICANT ADVERSE EVENTS/ADVERSE CLINICAL SEQUELAE ASSOCIATED WITH THE TIP FRACTURE OR ATTEMPTS TO RETRIEVE THE TIP.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MERCI RETRIEVER X6 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90066 UNK

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN