BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM

    MDR report key: 2212502 · Received May 16, 2011

    Report

    Report Number
    2183502-2011-00420
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    November 16, 2010
    Report Date
    November 17, 2010
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    LNY
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATOR REPORTED THAT THE DEVICE FAILURE AND DEVICE DISLOCATION WERE MILD IN INTENSITY AND RELATED TO THE INVESTIGATIONAL DEVICE; HOWEVER, THE INVESTIGATOR DID NOT CONSIDER THE EVENTS TO BE RELATED TO IDURSULFASE-IT OR IV ELAPRASE. THIS CASE WAS CONSIDERED SERIOUS FOR THE REPORTED EVENTS OF DEVICE FAILURE (HOSPITALIZATION) AND DEVICE DISLOCATION (MEDICALLY SIGNIFICANT). COMPANY COMMENT: THE COMPANY PHARMACOVIGILANCE PHYSICIAN ASSESSED THE CASE AND CONSIDERED THE REPORTED EVENT RELATED TO THE INTRATHECAL DRUG DELIVERY DEVICE (IDDD) FOR INFUSION OF ELAPRASE INTRATHECALLY. IT IS NOTED THAT THE IDDD PLACEMENT NEEDED REVISION TWICE; FIRST, A LARGE PORTION OF THE EXCESS TUBING WAS RESECTED ALONG WITH THE SCARRED TISSUE; SECOND, A NEW PORT WAS ATTACHED TO A NEWLY PLACED INTRATHECAL CATHETER. THIS CASE DOES NOT ALTER THE BENEFIT-RISK PROFILE OF ELAPRASE. ADD'L MFR NARRATIVE: CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL. (B)(4).

    Description of Event or Problem · 1

    PROXIMAL REVISION OF NON-FUNCTIONAL ACCESS PORT OF INTRATHECAL DRUG DELIVERY DEVICE (IDDD) [DEVICE FAILURE]. CATHETER DISLODGEMENT FROM INTRATHECAL SPACE REQUIRING REMOVAL OF IDDD AND PLACEMENT OF NEW IDDD [DEVICE DISLOCATION]. CASE DESCRIPTION: THIS (B)(6) REPORT DESCRIBES THE OCCURRENCE OF DEVICE FAILURE AND DEVICE DISLOCATION IN A (B)(6), MALE SUBJECT, PARTICIPATING IN (B)(4) PROTOCOL: (B)(4). THE SUBJECT HAD A REPORTED DRUG ALLERGY TO PENICILLIN. NO FURTHER MEDICAL HISTORY WAS PROVIDED. THE SUBJECT CONCOMITANTLY RECEIVED IV ELAPRASE (IDURSULFASE) FOR HUNTER SYNDROME. THE SUBJECT RECEIVED AN INTRATHECAL DRUG DELIVERY DEVICE ON (B)(6) 2010. ON (B)(6) 2010, THE SUBJECT WAS SCHEDULED TO RECEIVE HIS FIRST INJECTION OF IDURSULFASE-IT 10 MG VIA THE INTRATHECAL DRUG DELIVERY DEVICE. TWO ATTEMPTS WERE MADE TO ACCESS THE DEVICE USING A 22G 3/4" HUMBLER NEEDLE, WITH A TINY AMOUNT OF CEREBROSPINAL FLUID OBTAINED WITH DIFFICULTY. AN ATTEMPT TO FLUSH THE PORT WITH PRESERVATIVE FREE NORMAL SALINE WAS UNSUCCESSFUL. THEREFORE, DRUG WAS ADMINISTERED VIA LUMBAR PUNCTURE PER PROTOCOL. AN X-RAY OBTAINED ON (B)(6) 2010 SHOWED THE IDDD (INTRATHECAL DRUG DELIVERY DEVICE) IN THE CORRECT POSITION WITH NO EVIDENCE OF DISCONNECTION, KINKING OR DISLODGEMENT OF THE CATHETER. AN EXPLORATION WITH POSSIBLE REVISION OF THE IDDD WAS SCHEDULED. ON (B)(6) 2010, THE SUBJECT WAS ADMITTED TO HOSPITAL AND UNDERWENT A PROXIMAL REVISION. AN EXCESS AMOUNT OF COILED CATHETER APPEARED TO BE SCARRED DOWN TO THE SUBCUTANEOUS TISSUE AND A SMALL CREASE/KINK WAS NOTED FROM THE CATHETER TUBING IMMEDIATELY PRECEDING THE ACTUAL PORT ATTACHMENT. THEREFORE, A LARGE AMOUNT OF THE TUBING WAS REMOVED FROM THE SCAR TISSUE AND RESECTED ALTOGETHER, AND A SHORTENED PORTION OF TUBING COMING FROM THE INTRATHECAL CATHETER AND PUMP PORTION WAS ATTACHED DIRECTLY TO THE PORT. THE PORT WAS RETESTED WITH CONFIRMED CLEAR FLUID ASPIRATED. THE INCISION WAS CLOSED AND THE PT AWOKE FROM ANESTHESIA WITHOUT DIFFICULTY. AN X-RAY PERFORMED POST-OPERATIVELY ON (B)(6) 2010 SHOWED DISLODGEMENT OF THE INTRATHECAL CATHETER, WHICH WAS FOUND TO BE COILED IN THE SOFT TISSUE POSTERIOR TO THE SPINE WITH AN UNCLEAR POSITION OF THE CATHETER TIP. AS A RESULT, THE SUBJECT WAS TAKEN BACK TO THE OPERATING ROOM AND UNDERWENT REMOVAL OF HIS IDDD WITH PLACEMENT OF A NEW INTRATHECAL CATHETER UNDER FLUOROSCOPIC GUIDANCE. A NEW PORT WAS ATTACHED TO THE CATHETER. THE PORT WAS ACCESSED AND FLUID WAS EASILY ASPIRATED. THE SUBJECT WAS TRANSFERRED ONCE FULLY AWAKE BACK TO THE CHILDREN'S SHORT STAY UNIT FOR CONTINUED OBSERVATION. THE EVENTS WERE REPORTED AS RESOLVED ON (B)(6) 2010 AND THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM LNY - CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL LNY SMITHS MEDICAL MD 21-1500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| O| R ELAPRASE (IDURSULFASE) CONCENTRATE FOR SOLUTION| FOR INFUSION