BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 2932174 · Received January 25, 2013

    Report

    Report Number
    2182269-2013-00005
    Event Type
    Injury
    Date Received
    January 25, 2013
    Report Date
    January 4, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. (B)(6).

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY: VOLUME 23, NO. 8, (B)(6) 2012: A (B)(6) MAN UNDERWENT EMERGENT PERCUTANEOUS MESENTERIC ANGIOGRAPHY WITH TRANSARTERIAL EMBOLIZATION OF DYSPLASTIC DISTAL JEJUNAL COLIC ARTERY TO TREAT RECURRENT EPISODES OF LOWER GASTROINTESTINAL BLEEDING. THE PATIENT'S ONLY SIGNIFICANT MEDICAL HISTORY WAS A POSTTRAUMATIC SPLENECTOMY PERFORMED 9 MONTHS EARLIER WITHOUT REPORTED COMPLICATION. THE 5F PUNCTURE WAS INCREASED IN SIZE TO 6F DURING THE PROCEDURE. A RIGHT COMMON FEMORAL ARTERIOGRAM REVEALED APPROPRIATE ACCESS FOR A 6F ANGIO-SEAL. THE PATIENT TOLERATED THE PROCEDURE WELL BUT DEVELOPED SEVERE PAIN AROUND THE RIGHT FEMORAL ARTERY ACCESS SITE IMMEDIATELY AFTER DEPLOYMENT OF THE DEVICE BY THE ATTENDING INTERVENTIONAL RADIOLOGIST. THE PATIENT REQUIRED ADMISSION FOR INTRAVENOUS PAIN CONTROL AND FURTHER OBSERVATION. A MORE DETAILED PHYSICAL EXAMINATION DEMONSTRATED REDUCED SENSATION IN THE RIGHT THIGH IN THE DISTRIBUTION OF THE ANTERIOR FEMORAL CUTANEOUS BRANCHES OF THE FEMORAL NERVE. NO RELATED LOWER-EXTREMITY WEAKNESS WAS ELICITED. SONOGRAPHIC EVALUATION OF THE INCISION SITE REVEALED NORMAL VASCULAR ANATOMY AND APPROPRIATE POSITIONING OF THE COLLAGEN PLUG AND ANCHOR OF THE ANGIO-SEAL DEVICE. THERE WAS NO EVIDENCE OF EDEMA, HEMATOMA, OR VESSEL INJURY. THE PATIENT'S PAIN AND LOCALIZED HYPOESTHESIA WERE SUSPICIOUS FOR INJURY AND/OR ENTRAPMENT OF THE ANTERIOR CUTANEOUS BRANCHES OF THE FEMORAL NERVE BY THE ANGIO-SEAL COLLAGEN PLUG. AN ANESTHESIOLOGIST PERFORMED AN ULTRASOUND (US)-GUIDED NERVE BLOCK OF THE FEMORAL NERVE AT THE LEVEL OF THE INGUINAL LIGAMENT. THIS PROCEDURE RESULTED IN PROMPT RESOLUTION OF THE PATIENT'S PAIN. THE PATIENT WAS DISCHARGED 2 DAYS AFTER ADMISSION WITH ADEQUATE PAIN CONTROL WITH ORAL OPIOID AGENTS (OXYCODONE/ACETAMINOPHEN 5/325 MG). THE PATIENT PRESENTED 5 DAYS AFTER DISCHARGE WITH RECURRENT PAIN AT HIS ACCESS SITE. PHYSICAL EXAMINATION AGAIN DEMONSTRATED HYPOESTHESIA OF THE MEDIAL RIGHT THIGH. REPEAT US OF THE ACCESS SITE SHOWED NO INTERVAL VASCULAR COMPLICATIONS, ABSCESS, OR EDEMA. THE PATIENT RECEIVED A SECOND US-GUIDED BLOCK OF THE RIGHT FEMORAL NERVE IN THE SAME LOCATION BY THE SAME ANESTHESIOLOGIST, WITH REPEATED RESOLUTION OF PAIN. THE PATIENT WAS DISCHARGED 3 DAYS AFTER ADMISSION WITH ADEQUATE PAIN CONTROL WITH ORAL MEDICATIONS (OXYCODONE/ACETAMINOPHEN 5/325 MG). AT A 4-WEEK FOLLOW-UP APPOINTMENT, THE PATIENT REPORTED COMPLETE RESOLUTION OF THE PAIN AND DECREASED SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36159 ANGIO-SEAL DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R OXYCODONE 5 MG| ACETAMINOPHEN 325 MG