TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC
Report
- Report Number
- 1820334-2018-03698
- Event Type
- Injury
- Date Received
- December 20, 2018
- Date of Event
- November 10, 2018
- Report Date
- March 5, 2019
- Manufacturer
- COOK INC
- Product Code
- LJS
- UDI-DI
- 00827002239050
- PMA / PMN Number
- K132885
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION ¿ EVALUATION: THE COMPLAINT DEVICE WAS NOT RETURNED FOR AN EVALUATION. THERE ARE NO DEVICES FROM THE COMPLAINT LOT (9083312) REMAINING IN STOCK AT THE NORTH AMERICAN DISTRIBUTION CENTER (NADC) FOR EVALUATION. A DOCUMENT BASED INVESTIGATION WAS CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DRAWINGS, INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. THERE IS NO INFORMATION REGARDING THE SELECTION OF THIS CATHETER SIZE. PER THE INSTRUCTIONS FOR USE (IFU), CATHETER SIZE SHOULD BE AS SMALL AS THE USE WILL ALLOW. PRELIMINARY REPORTS INDICATE THAT CATHETER SIZE CAN INFLUENCE CLOTTING. LARGER DIAMETER CATHETERS HAVE MORE TENDENCIES TO PROMOTE CLOTS. VENOUS THROMBOEMBOLISMS ARE RELATED TO MANY FACTORS. PER A RECENT JOURNAL ARTICLE DISCUSSING INCREASED RATES OF DVT RELATED ARE THE INCREASED INSERTION OF CENTRAL VENOUS CATHETERS (CVC), PERIPHERALLY INSERTED CENTRAL CATHETERS (PICC). OTHER FACTORS CONSIDERED TO INCREASE THE RISK OF DVT-UE ARE ¿ IMMOBILIZATION, AND A HISTORY OF THROMBOEMBOLIC EVENTS. THE FORMATION OF A DVT-UE SEEMS TO BE PARTICULARLY FAVORED BY THE COMBINATION OF IRRITATION OF THE VESSEL WALL BY A CVC OR BY CHEMOTHERAPEUTICS AND TUMOR-RELATED HYPERCOAGULABILITY OF THE BLOOD. THE SECOND INDEPENDENT RISK FACTOR FOR DVT-UE IS MALIGNANT DISEASE. SURGICAL INTERVENTION IS THE THIRD PRINCIPAL RISK FACTOR FOR DVT-UE. (HEIL, ET AL). PATIENT HAD RISK FACTORS RELATED TO THROMBUS DEVELOPMENT. WE HAVE NO INFORMATION FOR THE USE OF ANTIBIOTICS. IT SHOULD ALSO BE NOTED THAT SMOKING IS ALSO A RISK FOR THROMBUS FORMATION. WE HAVE NOT INFORMATION REGARDING PATIENT¿S HYDRATION STATUS EVEN WITH TPN. ANOTHER RECENT ARTICLE INVOLVING 121 PATIENTS DISCUSSES, ¿HIGH CUMULATIVE INCIDENCE OF SVT WAS FOUND IN HIGH-RISK PATIENTS WITH CANCER, RECENT SURGERY AND PARENTERAL NUTRITION, IN SPITE OF ANTITHROMBOTIC PROPHYLAXIS.¿ (BEREA-BALTIERRA, ET AL.). THIS SAME ARTICLE CONCLUDED, ¿HIGH-OSMOLARITY AND HIGH-PROTEIN NUTRITION FORMULAS WERE SHOWN TO BE RISK FACTORS FOR SVT IN CANCER PATIENTS RECEIVING TPN.¿ (BEREA-BALTIERRA, ET AL.). THROMBOEMBOLISM (IF NOT TREATED) COULD RESULT IN A PULMONARY EMBOLISM AND POTENTIALLY CAUSE CRITICAL HARM. IT IS NOT WITHOUT VISUAL, DIMENSIONAL, AND/OR FUNCTIONAL TESTING OF THE PRODUCT, WE ARE UNABLE TO DETERMINE IF THIS IS A MANUFACTURING ISSUE. AT THIS TIME, MOST PROBABLE CAUSE OF THIS EVENT IS DISEASE PROGRESSION RELATED. CITATIONS ARE FROM: HEIL, J., MIESBACH, W., VOGL, T., O. BECHSTEIN, W., & REINISCH, A. (2017). DEEP VEIN THROMBOSIS OF THE UPPER EXTREMITY: A SYSTEMATIC REVIEW. DEUTSCHES ÄRZTEBLATT INTERNATIONAL, 114(14), 244¿249, HTTP://DOI.ORG/10.3238/ARZTEBL.2017.0244. RICARDO BEREA-BALTIERRA, RODOLFO RIVAS-RUIZ, [...], AND LAURA ESCOBEDO-HERNANDEZ (2014). RISK FACTORS FOR SUBCLAVIAN VEIN THROMBOSIS IN CANCER PATIENTS WITH TOTAL PARENTERAL NUTRITION, J CLIN MED RES. 2014;6(5):345-353, DOI: 10.14740/JOCMR1862W. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FINAL LOT, 9083312, RECORDED NO NON-CONFORMITIES. THE CATHETER SUBASSEMBLY COMPONENT LOT, IC9013165, AND THE CONTAINED CATHETER SUBASSEMBLY LOT, SA8967856, RECORDED NO NON-CONFORMITIES. A REVIEW OF COMPLAINT HISTORY RECORDS REVEALED TWO OTHER RELATED COMPLAINTS (WERE REPORTED FOR THE SAME LOT FOR THE SAME FAILURE MODE. DESPITE THE FACT THAT THERE WERE THREE COMPLAINTS REPORTED FOR LOT 9083312, THEY WERE ALL REPORTED FROM THE SAME FACILITY. THE FACILITY ALSO REPORTED FOUR OTHER COMPLAINTS FROM DIFFERENT LOT NUMBERS FOR THE SAME FAILURE MODE. THIS SUGGESTS THAT THE ISSUE MAY BE RELATED TO USE OR MAINTENANCE, AND NOT TO THE COMPLAINT DEVICE OR DEVICE LOT. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS PLAY AN IMPORTANT ROLE IN TREATMENT OF CRITICALLY ILL PATIENTS. HOWEVER, CATHETER TIPS CAN ERODE OR PERFORATE VASCULAR WALLS. EXTREME CAUTION MUST BE USED IN PLACEMENT AND MONITORING OF CATHETERS. PRECAUTIONS: SELECT PUNCTURE SITE AND LENGTH OF CATHETER NEEDED BY ASSESSING PATIENT ANATOMY AND CONDITION. IF LUMEN FLOW IS IMPEDED, DO NOT FORCE INJECTION OR WITHDRAWAL OF FLUIDS. NOTIFY ATTENDING PHYSICIAN IMMEDIATELY. PATIENT MOVEMENT CAN CAUSE CATHETER TIP DISPLACEMENT. CATHETER SIZE SHOULD BE AS SMALL AS USE WILL ALLOW. PRODUCT RECOMMENDATIONS: CATHETER SIZE AND PUNCTURE SITE- PRELIMINARY REPORTS INDICATE THAT CATHETER SIZE CAN INFLUENCE CLOTTING. LARGER DIAMETER CATHETERS HAVE MORE TENDENCY TO PROMOTE CLOTS. AS REPORTED¿CLOT FORMATION HAS LESS RELATION TO TYPE OF CATHETER MATERIAL THAN TO SIZE OF CATHETER. THE ANGLE OF THE CATHETER TIP TO THE VESSEL WALL SHOULD BE CHECKED CAREFULLY. IN ORDER TO GUARANTEE EXTRAPERICARDIAL LOCATION, THE CATHETER TIP SHOULD BE LOCATED ABOVE THE SVC-RA JUNCTION, WITHIN THE LOWER 1/3 OF THE SVC. EVERY EFFORT MUST BE MADE TO ASCERTAIN PROPER TIP POSITION IN ORDER TO PREVENT EROSION OR PERFORATION OF THE CENTRAL VENOUS SYSTEM AND TO ENSURE PROPER DELIVERY OF INFUSATES. CATHETER MAINTENANCE: CATHETER ENTRY SITE MUST BE PREPARED AND MAINTAINED IN A MANNER CONSISTENT WITH STANDARD PROCEDURE FOR CENTRAL VENOUS CATHETERIZATION. IF CATHETER IS NOT TO BE USED IMMEDIATELY, ITS LUMEN SHOULD BE MAINTAINED BY CONTINUOUS SALINE OR HEPARINIZED SALINE DRIP OR LOCKED WITH A CATHETER LOCKING SOLUTION. NOTE: IF MICROCLAVE OR OTHER NEEDLELESS ADAPTERS APPROVED FOR SALINE ONLY LOCK ARE USED, SALINE ONLY LOCK MAY BE USED. CATHETER LOCK SHOULD BE REESTABLISHED AFTER EVERY USE OR AT LEAST EVERY 24 HOURS IF UNUSED. LUMEN SHOULD BE FLUSHED WITH NORMAL SALINE BETWEEN ADMINISTRATION OF DIFFERENT INFUSATES. AFTER USE, LUMEN SHOULD AGAIN BE FLUSHED WITH TWICE THE INDICATED LUMEN VOLUME USING NORMAL SALINE BEFORE REESTABLISHING CATHETER LOCK. HOW SUPPLIED UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. WITH THE KNOWN INFORMATION ON THE DEVICE ITSELF, THERE IS NO EVIDENCE TO SUGGEST THE FAILURE MODE WAS MANUFACTURING RELATED. THE CUSTOMER STATED THAT THE PICC WAS LOCKED WITH NORMAL SALINE AND FLUSHED EVERY 12 HOURS WHEN NOT IN USE. THERE IS NO INFORMATION ON WHETHER MICROCLAVES OR NEEDLELESS ADAPTERS WERE USED, BUT THEY ARE REQUIRED IF A SALINE ONLY LOCK IS USED, PER THE DEVICE IFU. THE DEVICE WAS SECURED WITH A SECUR-A-CATH DEVICE, BUT IT IS STILL POSSIBLE THAT SOME MOVEMENT COULD OCCUR. THIS COULD CAUSE CATHETER TIP DISPLACEMENT, WHICH COULD CAUSE IRRITATION OF THE VESSEL WALLS, LEADING TO THROMBOSIS. FURTHERMORE, THE PATIENT HAD A HISTORY OF CANCER AND GALLSTONES PRIOR TO THE IMPLANTATION OF THE DEVICE AND WAS ALSO RECEIVING TPN. THESE PATIENT CONDITIONS INCREASE THE RISK FACTOR FOR THE DEVELOPMENT OF CLOTS AND THROMBOSIS, SO IT IS POSSIBLE THAT THEY CONTRIBUTED TO THE FAILURE MODE. THE PATIENT WAS ALSO A CURRENT SMOKER, WHICH IS ANOTHER RISK FOR THROMBUS FORMATION. HOWEVER, A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THE FAILURE MODE WAS MANUFACTURING RELATED. A QUALITY ENGINEER RISK ASSESSMENT WAS CONDUCTED TO ASSESS THE RISK OF THIS FAILURE MODE AND CONCLUDED NO RISK REDUCTION ACTIVITIES ARE REQUIRED AT THIS TIME. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.
IT WAS REPORTED IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 THAT A PATIENT HAD A COOK 5.0FR TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC PLACED ON (B)(6) 2018 IN THE LEFT ARM. THE CATHETER WAS 53CM IN LENGTH WITH 6CM EXPOSED, AND WAS SECURED WITH A SECUR-A-CATH DEVICE. WHEN NOT IN USE, THE PICC WAS FLUSHED EVERY 12 HOURS AND WAS LOCKED WITH NORMAL SALINE. THE PATIENT WAS NOTED TO BE AMBULATING INDEPENDENTLY. TREATMENT BEING ADMINISTERED THROUGH THE PICC INCLUDED THE FOLLOWING: PANTOPRAZOLE (INITIATED (B)(6) 2018; DISCONTINUED (B)(6) 2018), MEROPENEM (INITIATED (B)(6) 2018; DISCONTINUED (B)(6) 2018), CIPROFLOXACIN (INITIATED (B)(6) 2018, DISCONTINUED (B)(6) 2018), TPN (INITIATED (B)(6) 2018). VENOUS THROMBOEMBOLISM PROPHYLAXIS WAS INITIATED ON (B)(6) 2018, AND INCLUDED TINZAPRIN 4500 UNITS DAILY. SIX DAYS AFTER PLACEMENT, ON (B)(6) 2018, A THROMBUS EXTENDING INTO THE LEFT BASILIC VEIN ADJACENT TO THE PICC WAS DIAGNOSED. THE SUBCLAVIAN AND JUGULAR VEINS REMAINED PATENT. TREATMENT OF THE THROMBUS BEGAN ON (B)(6) 2018 WITH ENOXAPARIN 90MG, SUBCUTANEOUS, ONCE DAILY. THE PICC WAS REMOVED ON (B)(6) 2018 AND A NEW PICC WAS PLACED IN THE PATIENT'S RIGHT ARM AT THAT TIME. THE PATIENT HAD NO PRIOR HISTORY OF THROMBOSIS. NO FURTHER COMPLICATIONS FROM THE DEEP VEIN THROMBOSIS HAVE BEEN REPORTED.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
THE CUSTOMER REPORTED THEY RECEIVED AN ANECDOTAL REPORT OF THROMBUS FORMATION AROUND THE PICC LINES FOR SEVEN DIFFERENT PATIENTS. THIS RESULTED IN DEEP VEIN THROMBOSIS (DVT). ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. THE CUSTOMER HAS ADVISED THEY ARE SEEKING THE DETAILS OF THESE REPORTS. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS HAVE BEEN FORTHCOMING. THE FOLLOWING REPORTS ARE BEING FILED TO REPRESENT EACH OF THE INDICATED SEVEN PATIENTS. PATIENT 1, MANUFACTURER REPORT # 1820334-2018-03696. PATIENT 2, MANUFACTURER REPORT # 1820334-2018-03697. PATIENT 3, MANUFACTURER REPORT # 1820334-2018-03698. PATIENT 4, MANUFACTURER REPORT # 1820334-2018-03699. PATIENT 5, MANUFACTURER REPORT # 1820334-2018-03700. PATIENT 6, MANUFACTURER REPORT # 1820334-2018-03701. PATIENT 7, MANUFACTURER REPORT # 1820334-2018-03702.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1023214 | TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC | LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | LJS | COOK INC | G23905 | 9083312 | 00827002239050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other| R |