1820334-2022-00399
Report
- Report Number
- 1820334-2022-00399
- Event Type
- Injury
- Date Received
- March 16, 2022
- Date of Event
- March 3, 2022
- Report Date
- June 29, 2022
- Manufacturer
- COOK INC
- Product Code
- LJS
- UDI-DI
- 00827002531833
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BRAND NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER SET. CUSTOMER CONTACT INFORMATION: PHONE: (B)(6). OCCUPATION: SUPPLY MANAGER DEVICE NOT CLEARED FOR SALE IN THE US. A SIMILAR DEVICE IS CLEARED FOR SALE (C-UQLM-1001J-RSC-ABRM-HC-RD). THE PRO CODE OF THE SIMILAR DEVICE IS FOZ, 510(K): K081113. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
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.
INVESTIGATION ¿ EVALUATION. MACKAY BASE HOSPITAL INFORMED COOK THAT ON 03MAR2022 THE GUIDE WIRE IN A C-UQLM-1001J-RSC-ABRM-HC-RD-AU (COOK SPECTRUM CENTRAL VENOUS CATHETER MINOCYCLINE/RIFAMPIN ANTIBIOTIC IMPREGNATED POWER INJECTABLE) FROM LOT 13223095 HAD BROKEN UPON REMOVAL FROM INTRODUCER. GUIDE WIRE UNRAVELING LEAD TO INSERTION SITE (RIGHT FEMORAL ACCESS) BEING ABANDONED FOR A NEW INSERTION SITE (LEFT FEMORAL ACCESS). DUE TO CLINICAL CONDITION THE PATIENT WAS UNABLE TO LIE FLAT. THE WIRE GUIDE FRAGMENT WAS REMOVED BY A VASCULAR SURGEON. THE PHYSICIAN STATES THAT THE PROBLEM PREDOMINANTLY HAPPENS IN DEEPER VEIN CANNULATION WITH STEEPER NEEDLE APPROACH ANGLE. NO ADDITIONAL ADVERSE EFFECTS OCCURRED DUE TO THIS INCIDENT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK REVIEWED THE DEVICE HISTORY RECORD FOR LOT 13223095 AND RECORDS NO RELEVANT NON-CONFORMANCES. A SEARCH ON SUBASSEMBLY LOTS FOUND ONE RELATED NONCONFORMANCE FOR "COIL STRETCHED". THE NONCONFORMING DEVICE WAS SCRAPPED PRIOR TO FURTHER PROCESSING. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND 2 ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. THE FIRST COMPLAINT, FOR UNRAVELING WIRE, CONCLUDED COMPONENT FAILURE WITHOUT DESIGN OR MANUFACTURING DEFICIENCY. THE 2ND COMPLAINT, FOR THE SHEATH OF THE INTRODUCER NEEDLE BEING BENT, DOES NOT RELATE TO WIRE GUIDE UNRAVELING. BASED ON THE DEVICE MASTER RECORD, DEVICE HISTORY RECORD, AND REPRESENTATIVE DEVICE FAILURE ANALYSIS, THERE IS NO INDICATION THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_CTULMABRMAU_REV1] ¿COOK SPECTRUM CENTRAL VENOUS CATHETER MINOCYCLINE/RIFAMPIN ANTIBIOTIC IMPREGNATED POWER INJECTABLE,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: DO NOT CUT, TRIM OR MODIFY CATHETER OR COMPONENTS PRIOR TO PLACEMENT OR INTRAOPERATIVELY. INSTRUCTIONS FOR USE: ¿4. SLIDE SAFE-T-J WIRE GUIDE STRAIGHTENER (POSITIONED ON DISTAL TIP OF WIRE GUIDE) OVER ¿J¿ PORTION OF WIRE GUIDE. PASS STRAIGHTENED WIRE GUIDE THROUGH NEEDLE; ADVANCE WIRE GUIDE -10CM INTO VESSEL. IF STRAIGHT WIRE IS USED, ALWAYS ADVANCE SOFT, FLEXIBLE END THROUGH NEEDLE HUB AND INTO VESSEL. IF RESISTANCE IS ENCOUNTERED DURING WIRE GUIDE INSERTION, DO NOT FORCE WIRE GUIDE. WITHDRAWAL OF WIRE GUIDE THROUGH NEEDLE SHOULD BE AVOIDED: BREAKAGE MAY RESULT. 8. INTRODUCE THE CENTRAL VENOUS CATHETER OVER WIRE GUIDE. WHILE MAINTAINING WIRE GUIDE POSITION, ADVANCE CATHETER INTO VESSEL WITH A GENTLE TWISTING MOTION.¿ HOW SUPPLIED: ¿-UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS RELATED TO COMPONENT FAILURE. THE PHYSICIAN MENTIONS THAT THE DIFFICULTY IS NOTICED DURING THE FEMORAL APPROACH OR OBESE PATIENTS WITH DEEP CANNULATION. IT IS POSSIBLE THAT THE DIFFICULTY WITH PATIENT'S ANATOMY IS CONTRIBUTING TO THE GUIDE WIRE DAMAGE. HOWEVER, COOK IS UNABLE TO CONFIRM THIS. AS THERE IS NO EVIDENCE OF MANUFACTURING DEFICIENCIES, THE CAUSE OF THIS EVENT IS COMPONENT FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
IT WAS REPORTED THAT THE WIRE GUIDE IN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER SET UNRAVELED AND SEPARATED. THE DEVICE WAS REQUIRED FOR A RIGHT FEMORAL VEIN CENTRAL CATHETER INSERTION. DURING THE PROCEDURE, THE WIRE GUIDE UNRAVELED THEN SEPARATED UPON REMOVAL THROUGH THE DILATOR. AS A RESULT, A PORTION OF THE WIRE GUIDE WAS RETAINED IN THE PATIENT. THE INSERTION SITE WAS THEN CHANGED TO THE LEFT FEMORAL VEIN AND A NEW DEVICE WAS PLACED WITHOUT INCIDENT. THE SEPARATED WIRE GUIDE WAS UNABLE TO BE RETRIEVED SO THE FRAGMENT REMAINED IN THE PATIENT. THE PATIENT WAS THEN TRANSFERRED TO A FACILITY IN BRISBANE AND THE FRAGMENT WAS REMOVED BY A VASCULAR SURGEON. IT WAS NOTED THAT THE HOSPITAL TRANSFER WAS NOT DUE TO THE ISSUE WITH THE WIRE GUIDE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
ADDITIONAL INFORMATION PROVIDED 21MAR2022 STATED THE FOLLOWING: VENOUS CANNULATION WITH THE SUPPLIED NEEDLE AND FEEDING OF THE WIRE WAS UNEVENTFUL. THERE WAS NO NOTE OF ISSUES REMOVING THE NEEDLE OVER THE WIRE. THE ISSUE ORIGINATED DURING DILATION OVER THE WIRE, ESPECIALLY WITH THE SECOND DILATOR. THE WIRE BECAME BENT DURING DILATION, NOTED DUE TO RESISTANCE REMOVING THE DILATOR. THIS APPEARS TO BE MORE PROMINENT IN CASES WITH DEEPER VEIN CANNULATION WITH A STEEPER NEEDLE APPROACH ANGLE (ESPECIALLY FEMORAL ACCESS). THE USER STATED THE WIRE SEEMS TOO WEAK.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508383 | LJS | COOK INC | N/A | 13223095 | 00827002531833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R |