FDA Adverse Event Malfunction Summary report: N

MERCI RETRIEVER 6X

MDR report key: 598883 · Received April 26, 2005

Report

Report Number
2954917-2005-00006
Event Type
Malfunction
Date Received
April 26, 2005
Date of Event
March 31, 2005
Report Date
April 25, 2005
Manufacturer
CONCENTRIC MEDICAL, INC.
Product Code
NRY
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

DURING TREATMENT OF A PT WITH AN ANEURYSM, THE TIP OF A MICRO THERAPEUTICS X-PEDION GUIDEWIRE FRACTURED LEAVING AN 8 CM FRAGMENT IN THE DISTAL VERTABRAL ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE GUIDEWIRE FRAGMENT USING A BSC IN-TIME AND A MICROVENA SNARE BEFORE USING THE MERCI RETRIEVER X6. HE ENSNARED THE GUIDEWIRE FRAGMENT WITH THE RETRIEVER, BUT THE GUIDEWIRE FRAGMENT DEFORMED, OCCLUDING BLOOD FLOW IN THE VESSEL AND DAMAGING THE RETRIEVER X6. HE USED THE SAME DEVICE IN A SECOND ATTEMPT TO RETRIEVE THE GUIDEWIRE FRAGMENT AND FRACTURED THE MERCI RETRIEVER X6 HELICAL TIP, LEAVING THE RETRIEVER X6 TIP IN THE SAME AREA AS THE GUIDEWIRE FRAGMENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICES USING A 2ND IN-TIME DEVICE; A SMALL DISSECTION RESULTED, THE PHYSICIAN THEN DISCONTINUED THE PROCEDURE. THE RETRIEVER X6 IFU WARNS AGAINST USING DAMAGED DEVICES. NO CLINICAL SEQUELAE WERE ASSOCIATED WITH THE FRACTURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MERCI RETRIEVER 6X CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90066 UNK

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN