CENTRAL VENOUS CATHETER
Report
- Report Number
- 1820334-2012-00397
- Event Type
- Injury
- Date Received
- August 15, 2012
- Report Date
- June 19, 2019
- Manufacturer
- COOK, INC.
- Product Code
- FOZ
- PMA / PMN Number
- K081113
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
EXPIRATION DATE: UNK AS LOT NUMBER IS UNK. (B)(6). THE ARTICLE FROM ANATOMIC PATHOLOGY. EMBOLIZATION HYDROPHILIC CATHETER COATING TO THE LUNGS. AM J CLIN PATHOL 2009; 132:794-797. DEVICE AGE: UNK AS LOT NUMBER IS UNK. (B)(4). DEVICE MANUFACTURE DATE: UNK AS LOT NUMBER IS UNK. EVENT IS STILL UNDER INVESTIGATION.
INITIAL REPORTER FROM INTERNAL PERSONNEL THE ARTICLE FROM ANATOMIC PATHOLOGY EMBOLIZATION OF HYDROPHILIC CATHETER COATING TO THE LUNGS AM J CLIN PATHOL 2009, 132 794-797.
INVESTIGATION - EVALUATION: A REVIEW OF DOCUMENTATION INCLUDING THE INSTRUCTIONS FOR USE, QUALITY CONTROL AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. ALTHOUGH THE DEVICE WAS NOT RETURNED, THERE WAS NO EVIDENCE PROVIDED IN THE ARTICLE TO SUGGEST THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF DEVICES FOR THE REPORTED COMPLAINT DEVICE DESCRIPTION. BASED ON THE DESCRIPTION AND A SALES REPORT, THE DEVICE WAS LIKELY A C-UTLM-701J-ABRM-HC SET. BASED ON THIS INFORMATION, A REVIEW OF THE PRODUCT DEVICE MASTER RECORD EXAMINING PRODUCT LABELING, SPECIFICATIONS AND QUALITY CONTROL INSTRUCTIONS WAS CONDUCTED. IT WAS CONCLUDED THAT SUFFICIENT CONTROLS AND INSPECTIONS ARE IN PLACE TO PREVENT THE RELEASE OF NONCONFORMING PRODUCT RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED, AS THE LOT INFORMATION IS UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST NONCONFORMING DEVICES IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED INTENDED USE THE ACTIVITY OF THE ANTIMICROBIAL AGENTS, MINOCYCLINE AND RIFAMPIN, IS LOCALIZED AT THE INTERNAL AND EXTERNAL CATHETER SURFACE AND HELPS TO PROVIDE PROTECTION AGAINST CATHETER-RELATED BLOODSTREAM INFECTIONS (CRBSI). IT IS NOT INTENDED FOR TREATMENT OF EXISTING INFECTION. CONTRAINDICATIONS MINOCYCLINE AND RIFAMPIN ARE AGENTS THAT DO NOT INDUCE ANY GENOTOXIC RISKS EXCEPT A POSSIBLE TERATOGENIC EFFECT IN PREGNANT WOMEN. WE THEREFORE DO NOT RECOMMEND THE USE OF SPECTRUM OR SPECTRUM GLIDE CATHETER IN PREGNANT WOMEN. WARNINGS IN RARE CASES, HEPATOTOXICITY, SYSTEMIC LUPUS ERYTHEMATOSUS AND EXACERBATION OF PORPHYRIA HAVE BEEN ASSOCIATED WITH THE SYSTEMIC USE OF MINOCYCLINE AND/OR RIFAMPIN. PRECAUTIONS PRIOR TO INSERTION, THE COOK SPECTRUM OR SPECTRUM GLIDE CATHETER SHAFT SHOULD NOT BE WIPED WITH OR IMMERSED IN ETHYL ALCOHOL, ISOPROPYL ALCOHOL, OR OTHER ALCOHOLS, ACETONE OR OTHER NON-POLAR SOLVENTS. THESE SOLVENTS MAY REMOVE THE ANTIMICROBIAL FROM THE CATHETER AND REDUCE THE CATHETER¿S ANTIMICROBIAL EFFICACY. HOW SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGED. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE FAILURE MODE FOR THE COMPLAINT WAS HYDROPHILIC COATING SEPARATING FROM THE DEVICE. A DEFINITIVE CONCLUSION AS TO HOW THIS HAPPENED WAS UNABLE TO BE ESTABLISHED. ALL CATHETERS FITTING THE COMPLAINT DEVICE DESCRIPTION UNDERGO 100% INSPECTION FOR THE HYDROPHILIC COATING NOT SEPARATING OR LIFTING OFF THE DEVICE. IT IS POSSIBLE THAT REPETITIVE MOVEMENT OF THE CATHETER, AS DESCRIBED IN THE ARTICLE, MAY HAVE CONTRIBUTING TO THE COATING COMING OFF, BUT CANNOT BE CONFIRMED. APPROPRIATE MEASURES HAVE BEEN TAKEN TO ADDRESS THIS FAILURE MODE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.
(B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
PER ARTICLE FROM ANATOMIC PATHOLOGY, EMBOLIZATION OF HYDROPHILIC CATHETER COATING TO THE LUNGS. AM J CLIN PATHOL 2009; 132:794-797. REPORT OF A CASE: THE PT WAS A (B)(6) WOMEN WITH A HISTORY OF SCHIZOPHRENIA WHO WAS EVALUATED AT AN OUTSIDE HOSPITAL FOR HEMATOCHEZIA AND RECTAL PAIN AND WHO SUBSEQUENTLY UNDERWENT HEMORRHOIDECTOMY. ENDOSCOPY REVEALED THE PRESENCE OF A PERIANAL ABSCESS AND FISTULA TRACTS. RECTAL BIOPSIES SHOWED ACTIVE CHRONIC INFLAMMATION WITHOUT GRANULOMATA, AND THE FINDINGS WERE CLINICALLY CONSISTENT WITH CROHN DISEASE. THERAPY WITH MESALAMINE (ASACOL), CIPROFLOXACIN AND METRONIDAZOLE WAS INITIATED. LOW-GRADE FEVERS DEVELOPED, AND COMPUTED TOMOGRAPHY (CT) SCARS OF THE ABDOMEN AND PELVIS WERE PERFORMED, WHICH REVEALED THICKENING OF THE SIGMOID AND RECTUM. IN ADDITION, NODULES IN BOTH LUNG BASES WERE NOTED. A FOLLOW-UP CHEST CT SCAN SHOWED MULTIPLE SCATTERED PULMONARY NODULES WITH CAVITATIONS THAT WERE SUGGESTIVE OF SEPTIC EMBOLI. BLOOD CULTURES GREW COAGULASE-NEGATIVE STAPHYLOCOCCUS. TWELVE DAYS EARLIER, A TRIPLE-LUMEN CENTRAL VENOUS CATHETER HAD BEEN INSERTED WITHOUT DIFFICULTY OR APPARENT COMPLICATION. IT WAS A SPECTRUM GLIDE, 7.0 FRENCH, TRIPLE LUMEN CENTRAL VENOUS CATHETER <IMPREGNATED WITH MINOCYCLINE AND RIFAMPIN AND HAVING A HYDROPHILIC POLYMER (EZ-PASS) COATING ON THE DISTAL 10CM>. TRANSESOPHAGEAL ECHOCARDIOGRAPHY NOW SHOWED A THROMBUS IN THE SUPERIOR VENA CAVA THAT WAS ASSOCIATED WITH THE CENTRAL VENOUS CATHETER; THERE WERE NO VALVULAR VEGETATIONS. THE CENTRAL VENOUS CATHETER WAS REMOVED, AND A PERIPHERALLY INSERTED CENTRAL CATHETER WAS PLACED. SEROLOGIC STUDIES SHOWED A POSITIVE P-ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA); C-ANCA AND ANTIMYELOPER-OXIDASE ANTIBODY WERE NEGATIVE. ANTINUCLEAR ANTIGEN WAS NEGATIVE. HEPATITIS A, B, AND C SEROLOGIC TEST RESULTS WERE NEGATIVE. C-REACTIVE PROTEIN WAS ELEVATED, AT 101.4 MG/L (965.7 NMOL/L; REFERENCE RANGE, 0.0-4.9 MG/L [0.0-46.7 NMOL/L]). THE PT QUIT SMOKING 8 MONTHS PREVIOUSLY, AND THERE WAS A REMOTE HISTORY COCAINE AND MARIJUANA USE (NONE WITHIN THE LAST YEAR). AN HIV TEST WAS NEGATIVE. TRANSBRONCHIAL BIOPSY WAS PERFORMED, AND MICROSCOPY SHOWED NO DIAGNOSTIC ABNORMALITY. BRONCHOALVEOLAR LAVAGE CULTURE WAS NEGATIVE FOR BACTERIA, FUNGI, AND ACID-FAST BACILLI. IMMUNOFLUORESCENCE FOR RESPIRATORY VIRUSES AND CYTOMEGALOVIRUS WAS NEGATIVE. WEDGE BIOPSIES OF THE RIGHT UPPER AND MIDDLE LOBES WERE PERFORMED. A FOLLOW-UP CT SCAN 8 WEEKS LATER SHOWED MARKED DIMINUTION IN THE CAVITARY PULMONARY NODULES. PT EXPERIENCED THROMBUS IN THE SUPERIOR VENA CAVA.
PER ARTICLE FROM ANATOMIC PATHOLOGY, EMBOLIZATION OF HYDROPHILIC CATHETER COATING TO THE LUNGS AM J CLIN PATHOL 2009, 132 794-797. REPORT OF A CASE THE PATIENT WAS A (B)(6) AFRICAN AMERICAN WOMAN WITH A HISTORY OF SCHIZOPHRENIA WHO WAS EVALUATED AT AN OUTSIDE HOSPITAL FOR HEMATOCHEZIA AND RECTAL PAIN AND WHO SUBSEQUENTLY UNDERWENT HEMORRHOIDECTOMY. ENDOSCOPY REVEALED THE PRESENCE OF A PERIANAL ABSCESS AND FISTULA TRACTS. RECTAL BIOPSIES SHOWED ACTIVE CHRONIC INFLAMMATION WITHOUT GRANULOMATA, AND THE FINDINGS WERE CLINICALLY CONSISTENT WITH CROHN DISEASE THERAPY WITH MESALAMINE (ASACOL), CIPROFLOXACIN AND METRONIDAZOLE WAS INITIATED. LOW-GRADE FEVERS DEVELOPED, AND COMPUTED TOMOGRAPHY (CT) SCANS OF THE ABDOMEN AND PELVIS WERE PERFORMED, WHICH REVEALED THICKENING OF THE SIGMOID AND RECTUM IN ADDITION, NODULES IN BOTH LUNG BASES WERE NOTED A FOLLOW-UP CHEST CT SCAN SHOWED MULTIPLE SCATTERED PULMONARY NODULES WITH CAVITATIONS THAT WERE SUGGESTIVE OF SEPTIC EMBOLI BLOOD CULTURES GREW COAGULASE-NEGATIVE STAPHYLOCOCCUS TWELVE DAYS EARLIER, A TRIPLE-LUMEN CENTRAL VENOUS CATHETER HAD BEEN INSERTED WITHOUT DIFFICULTY OR APPARENT COMPLICATION IT WAS A SPECTRUM GLIDE, 7 0 FRENCH, TRIPLE LUMEN CENTRAL VENOUS CATHETER <IMPREGNATED WITH MINOCYCLINE AND RIFAMPIN AND HAVING A HYDROPHILIC POLYMER (EZ-PASS) COATING ON THE DISTAL 10CM> TRANSESOPHAGEAL ECHOCARDIOGRAPHY NOW SHOWED A THROMBUS IN THE SUPERIOR VENA CAVA THAT WAS ASSOCIATED WITH THE CENTRAL VENOUS CATHETER, THERE WERE NO VALVULAR VEGETATIONS THE CENTRAL VENOUS CATHETER WAS REMOVED, AND A PERIPHERALLY INSERTED CENTRAL CATHETER WAS PLACED SEROLOGIC STUDIES SHOWED A POSITIVE P-ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA), C-ANCA AND ANTIMYELOPER-OXIDASE ANTIBODY WERE NEGATIVE ANTINUCLEAR ANTIGEN WAS NEGATIVE HEPATITIS A, B, AND C SEROLOGIC TEST RESULTS WERE NEGATIVE C-REACTIVE PROTEIN WAS ELEVATED, AT 101 4 MG/L (965 7 NMOL/L, REFERENCE RANGE, 0 0-4 9 MG/L [0 0-46 7 NMOLIL]) THE PATIENT QUIT SMOKING 8 MONTHS PREVIOUSLY, AND THERE WAS A REMOTE HISTORY OF COCAINE AND MARIJUANA USE (NONE WITHIN THE LAST YEAR) AN HIV TEST WAS NEGATIVE TRANSBRONCHIAL BIOPSY WAS PERFORMED, AND MICROSCOPY SHOWED NO DIAGNOSTIC ABNORMALITY BRONCHOALVEOLAR LAVAGE CULTURE WAS NEGATIVE FOR BACTERIA, FUNGI, AND ACID-FAST BACILLI IMMUNOFLUORESCENCE FOR RESPIRATORY VIRUSES AND CYTOMEGALOVIRUS WAS NEGATIVE WEDGE BIOPSIES OF THE RIGHT UPPER AND MIDDLE LOBES WERE PERFORMED A FOLLOW-UP CT SCAN 8 WEEKS LATER SHOWED MARKED DIMINUTION IN THE CAVITARY PULMONARY NODULES PATIENT EXPERIENCED THROMBUS IN THE SUPERIOR VENA CAVA A FOLLOW-UP CT SCAN 8 WEEKS LATER SHOWED MARKED DIMINUTION IN THE CAVITARY PULMONARY NODULES INVESTIGATION / EVALUATION NO PRODUCT WAS RETURNED TO ASSIST IN THE INVESTIGATION PER QUALITY CONTROL SPECIFICATION, THERE IS 100% VERIFICATION THAT THE COATING IS SMOOTH, FREE OF BUBBLES AND FOREIGN MATTER IT IS ALSO VERIFIED THAT THE LUBRICITY AND DURABILITY ARE SUFFICIENT ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED WITHOUT ADDITIONAL INFORMATION THE ROOT CAUSE OF THIS EVENT REMAINS UNKNOWN WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE INTERNAL PERSONNEL HEALTH RISK ASSESSMENT (HRA) AND QUALITY ENGINEERING RISK ASSESSMENT WERE CREATED IN RESPONSE TO THIS COMPLAINT PER THE CONCLUSION OF THE ASSESSMENT, IT WAS DETERMINED THAT RISK REDUCTION IS NOT NECESSARY AT THIS TIME CVCS PROVIDE CRUCIAL CENTRAL VENOUS ACCESS REQUIRED FOR THE CARE OF CRITICALLY ILL PATIENTS AND IT IS CONCLUDED THAT THE BENEFITS ASSOCIATED WITH HYDROPHILICALLY COATED CVCS OUTWEIGH THE RISKS.
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
IT WAS REPORTED THAT A PATIENT DEVELOPED CAVITARY PULMONARY NODULES AND A MURAL THROMBUS AFTER THE PLACEMENT OF A COOK SPECTRUM GLIDE, 7.0 FRENCH TRIPLE-LUMEN CENTRAL VENOUS CATHETER IMPREGNATED WITH MINOCYCLINE AND RIFAMPIN WITH A HYDROPHILIC COATING. THE PATIENT WAS A (B)(6) YEAR-OLD AFRICAN AMERICAN WOMAN WITH A HISTORY OF SCHIZOPHRENIA WHO WAS EVALUATED AT AN OUTSIDE HOSPITAL FOR HEMATOCHEZIA AND RECTAL PAIN. THE PATIENT SUBSEQUENTLY UNDERWENT HEMORRHOIDECTOMY. ENDOSCOPY REVEALED THE PRESENCE OF A PERIANAL ABSCESS AND FISTULA TRACTS. RECTAL BIOPSIES SHOWED ACTIVE CHRONIC INFLAMMATION WITHOUT GRANULOMATA, AND THE FINDINGS WERE CLINICALLY CONSISTENT WITH CROHN'S DISEASE. A COOK SPECTRUM GLIDE TRIPLE LUMEN CVC WAS PLACED WITHOUT ANY DIFFICULTY OR APPARENT COMPLICATION. MESALAMINE (ASACOL), CIPROFLOXACIN,AND METRONIDAZOLE THERAPY WAS INITIATED THROUGH THE DEVICE. LOW-GRADE FEVERS DEVELOPED, AND COMPUTED TOMOGRAPHY (CT) SCANS OF THE ABDOMEN AND PELVIS WERE PERFORMED, WHICH REVEALED THICKENING OF THE SIGMOID AND RECTUM. IN ADDITION, NODULES IN BOTH LUNG BASES WERE NOTED. A FOLLOW-UP CHEST CT SCAN SHOWED MULTIPLE SCATTERED PULMONARY NODULES WITH CAVITATIONS THAT WERE SUGGESTIVE OF SEPTIC EMBOLI. BLOOD CULTURES GREW COAGULASE-NEGATIVE STAPHYLOCOCCUS. TRANSESOPHAGEAL ECHOCARDIOGRAPHY SHOWED A THROMBUS IN THE SUPERIOR VENA CAVA THAT WAS ASSOCIATED WITH THE CENTRAL VENOUS CATHETER; THERE WERE NO VALVULAR VEGETATIONS. THE CENTRAL VENOUS CATHETER WAS REMOVED, AND A PERIPHERALLY INSERTED CENTRAL CATHETER WAS PLACED. SEROLOGIC STUDIES SHOWED A POSITIVE P-ANTINEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA); C-ANCA AND ANTIMYELOPEROXIDASE ANTIBODY WERE NEGATIVE. ANTINUCLEAR ANTIGEN WAS NEGATIVE. HEPATITIS A, B, AND C SEROLOGIC TEST RESULTS WERE NEGATIVE. C-REACTIVE PROTEIN WAS ELEVATED, AT 101.4 MG/L (965.7 NMOL/L; REFERENCE RANGE, 0.0-4.9 MG/L [0.0-46.7NMOL/L]). THE PATIENT QUIT SMOKING 8 MONTHS PREVIOUSLY, AND THERE WAS A REMOTE HISTORY OF COCAINE AND MARIJUANA USE (NONE WITHIN THE LAST YEAR). AN HIV TEST WAS NEGATIVE. TRANSBRONCHIAL BIOPSY WAS PERFORMED, AND MICROSCOPY SHOWED NO DIAGNOSTIC ABNORMALITY. BRONCHOALVEOLAR LAVAGE CULTURE WAS NEGATIVE FOR BACTERIA, FUNGI, AND ACID-FAST BACILLI. IMMUNOFLUORESCENCE FOR RESPIRATORY VIRUSES AND CYTOMEGALOVIRUS WERE NEGATIVE. WEDGE BIOPSIES OF THE RIGHT UPPER AND MIDDLE LOBES WERE PERFORMED. EACH WEDGE BIOPSY MEASURED 5 CM IN MAXIMAL DIMENSION. GROSSLY, BOTH SPECIMENS CONTAINED MULTIPLE CAVITARY NODULES, UPS TO .08 CM IN DIAMETER, WITH CENTRAL PURULENT MATERIAL. FUNGAL CULTURE GREW PENICILLIUM SPECIES, WHICH WAS CONSIDERED CONTAMINANT. MICROSCOPY REVEALED PATCHY ANGIOCENTRIC GRANULOMAS WITH MULTINUCLEATED GIANT CELLS AND MICROABSCESSES CONTAINING NUMEROUS NEUTROPHILS AND SCATTERED EOSINOPHILS. NUMEROUS ILL-DEFINED SERPIGINOUS STRUCTURES WERE IDENTIFIED NOT ONLY IN THE GRANULOMATOUS AREAS BUT ALSO IN THE MICROABSCESS AND WITHIN SEVERAL ARTERIAL LUMENS. WITH H&E STAINING, THE MATERIAL IS AMORPHOUS, NONRETRACTILE, NONPOLARIZABLE, AND PINK-PURPLE TO BLUE-GREY. ITS APPEARANCE WAS CONSISTENT WITH HYDROPHILIC POLYMER, AS HAS BEEN PREVIOUSLY DESCRIBED FROM VASCULAR SHEATH AND CATHETER COATINGS. BASED ON THE MICROSCOPIC FINDINGS AND THE CLINICAL HISTORY, A DIAGNOSIS WAS MADE OF CAVITATING ANGIOCENTRIC GRANULOMATOUS PULMONARY NODULES DUE TO EMBOLIZATION OF HYDROPHILIC COATING FROM A CENTRAL VENOUS CATHETER. A FOLLOW-UP CT SCAN 8 WEEKS LATER SHOWED MARKED DIMINUTION IN THE CAVITARY PULMONARY NODULES. THE PREVIOUS REPORT INDICATED "OCCLUSION WITHIN DEVICE." THIS REPORT IS TO CAPTURE THE CAVITARY PULMONARY NODULES THAT WERE REPORTED AS A RESULT OF THE HYDROPHILIC COATING AND THE CORRECTION REGARDING THE DEVELOPMENT OF A MURAL THROMBUS IN THE SUPERIOR VENA CAVA ASSOCIATED WITH THE CENTRAL VENOUS CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 0 | CENTRAL VENOUS CATHETER | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | COOK, INC. | NA | UNK | |
| 1 | CENTRAL VENOUS CATHETER SET | FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | COOK INC | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Life Threatening| R |