BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER, CONTINOUS FLUSH

    MDR report key: 6745343 · Received July 26, 2017

    Report

    Report Number
    2954740-2017-00219
    Event Type
    Injury
    Date Received
    July 26, 2017
    Date of Event
    September 27, 2006
    Report Date
    June 30, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL/FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #2954740-2017-00219. THE LITERATURE ARTICLE ASSOCIATED WITH THIS EVENT IS ATTACHED TO THIS REPORT. CONCLUSION: BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOTS FOR THE PRODUCTS ARE UNKNOWN. ANEURYSM PERFORATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH BOTH THE CODMAN EMBOLIC COILS AND THE CODMAN MICROCATHETER DEVICES AND IS LISTED IN THE IFUS AS SUCH. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT ANATOMY OF THE TARGET LESION AND INTRA-PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW(S) OF COMPLAINT HISTORY(IES) FOR THE DEVICE(S). NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿PREVENTION AND MANAGEMENT OF INTRAPROCEDURAL RUPTURE OF INTRACRANIAL ANEURYSM WITH DETACHABLE COILS DURING EMBOLIZATION¿ BY MING-HUA LI, BU-LANG GAO, CHUN FANG, YING-SHENG CHENG, YONG-DONG LI, JUE WANG, GUO-PING XU, PUBLISHED NEURORADIOLOGY (2006) 48:907¿915 DOI 10.1007/S00234-006-0147-3, PERFORATION OF THE ANEURYSM WALL WAS REPORTED IN CASE 8 DURING THE COILING PROCEDURE. PER THE ARTICLE; 284 PATIENTS WITH CEREBRAL ANEURYSMS WERE TREATED WITH DETACHABLE COILS. INTRAPROCEDURAL ANEURYSM RUPTURE OCCURRED IN TEN PATIENTS WITH A HISTORY OF A PREVIOUSLY RUPTURED ANEURYSM. IN CASE 8, (B)(6)-YEAR-OLD FEMALE PRESENTED WITH AN ANTERIOR COMMUNICATING ARTERY ANEURYSM THAT RE-RUPTURED DURING THE COILING PROCEDURE. THE RUPTURE WAS RELATED TO BOTH THE MICROCATHETER TIP (PROWLER CATHETER) AND THE COIL (CODMAN DCS COIL). IN THIS SITUATION, THE TIP OF THE MICROCATHETER WAS IN CLOSE CONTACT WITH THE ANEURYSM WALL AND DELIVERY OF THE COILS PERFORATED THE ANEURYSM WALL. HOWEVER, CONTINUED EMBOLIZATION DID NOT RENDER THIS PATIENT PARALYZED. PATIENT OUTCOME WAS REPORTED TO BE GOOD. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED ON A MONTHLY BASIS FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525477 CATHETER, CONTINOUS FLUSH KRA CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention