FDA Adverse Event Malfunction Summary report: N

MERCI MICROCATHETER 18L

MDR report key: 1934421 · Received November 23, 2010

Report

Report Number
2954917-2010-00015
Event Type
Malfunction
Date Received
November 23, 2010
Report Date
November 22, 2010
Manufacturer
CONCENTRIC MEDICAL, INC.
Product Code
DQO
PMA / PMN Number
K003086
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

SOURCE: JOURNAL ARTICLE IN MODERN PATHOLOGY (2010) 23, 921-930 TITLED "HYDROPHILIC POLYMER EMBOLI: AN UNDER-RECOGNIZED IATROGENIC CAUSE OF ISCHEMIA AND INFARCT" BY RUPAL I, MEHTA ET AL. (UCLA, LOS ANGELES, CA, USA). THE ARTICLE WAS RECEIVED BY THE JOURNAL ON 17 NOVEMBER 2009; REVISED AND ACCEPTED 18 FEBRUARY 2010; AND PUBLISHED ONLINE 19 MARCH 2010. THE ARTICLE REPORTS NINE (9) CASES OF FOREIGN BODY EMBOLI IN PTS WHO UNDERWENT VASCULAR PROCEDURES USING HYDROPHILIC-COATED MEDICAL DEVICES. ONE OF THESE 9 CASES (CALLED CASE 6) INVOLVED SEVERAL HYDROPHILIC COATED DEVICES, ONE OF WHICH WAS A CONCENTRIC MEDICAL DEVICE - MICROCATHETER 18L. IN THE CASE INVOLVING THE MICROCATHETER 18L, A (B)(6) MALE WAS UNDERGOING CEREBRAL ANGIOGRAPHY IN 4 VESSELS TO PREPARE FOR REMOVAL OF AN OCCLUSION IN THE LEFT MIDDLE CEREBRAL ARTERY. AFTER THE PROCEDURE, IMAGE STUDIES SHOWED MULTIPLE SMALL EMBOLI WITHIN DISTAL BRANCHES OF THE LEFT ANTERIOR AND MIDDLE CEREBRAL ARTERIES. THREE DAYS AFTER ANGIOGRAPHY, HISTOLOGIC EXAMINATION AFTER SURGICAL BIOPSY OF A PARENCHYMAL HEMATOMA SHOWED LAMELLATED, NON-REFRACTILE, NON POLARIZABLE, GRANULAR, BASOPHILIC FOREIGN INTRAVASCULAR MATERIAL. SIX ARTERIOLES WERE AFFECTED IN THREE TISSUE SECTIONS EXAMINED. THE ARTICLE LISTED "STROKE WITH HEMIPARESIS, APHASIA" AS CLINICAL SEQUELAE IN THIS CASE. IN ADDITION TO THE MICROCATHETER MC18L, THE FOLLOWING INTRAVASCULAR MEDICAL DEVICES, SEVERAL OF WHICH HAVE A HYDROPHILIC COATING, WERE USED: MEDI-TECH 8F SHEATH, 0.035 COOK BENTSON GUIDEWIRE, 5F GLIDE CATHETER, CONCENTRIC 8F BALLOON GUIDE CATHETER, TERUMO GUIDEWIRE, 6F PERCLOSE, BOSTON SCIENTIFIC FASDASHER 14 MICROGUIDEWIRE. WHILE THE CONCENTRIC MEDICAL MICROCATHETER 18L DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G. PT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MERCI MICROCATHETER 18L CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CONCENTRIC MEDICAL, INC. 90044 UNK

Patients

Seq Age Sex Outcome Treatment
1 54 YR Other