LIVER ACCESS AND BIOPSY SET
Report
- Report Number
- 1820334-2023-01657
- Event Type
- Malfunction
- Date Received
- December 7, 2023
- Date of Event
- November 27, 2023
- Report Date
- March 6, 2024
- Manufacturer
- COOK INC
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4- THESE FIELDS ARE UNAVAILABLE FOR THIS DEVICE AS IT IS NOT SOLD IN THE U.S.; HOWEVER, THIS DEVICE MEETS THE QUALIFICATIONS FOR A DEVICE THAT IS SAME/SIMILAR TO ONE THAT IS SOLD IN THE U.S., THUS PROMPTING THIS REPORT. DATA FOR THE LIKE DEVICE IS AS FOLLOWS: D2A- COMMON NAME: DYB INTRODUCER, CATHETER; D2B- PRODUCT CODE: DYB; G4- PMA/510(K) #: K171853. 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.
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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE BLACK CATHETER OF A LIVER ACCESS AND BIOPSY SET SHEARED. DIFFICULTY WAS EXPERIENCED DURING ADVANCEMENT THROUGH CURVED VASCULATURE INTO THE SUPRA HEPATIC ARTERY OF THE PATIENT WITH TORTUOUS ANATOMY. AFTER A FEW ATTEMPTS, IT WAS DISCOVERED THAT THE CATHETER WAS "ATTACHED" TO THE SHEATH AND COULD NOT ADVANCE. THE DEVICE WAS REMOVED, AND NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, SPECIFICATIONS, AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED DEVICE INCLUDING THE SHEATH, STIFFENING CANNULA, AND BLACK CATHETER WAS RETURNED TO COOK FOR EVALUATION. THE BLACK CATHETER APPEARED TO BE SHEARED AT APPROXIMATELY 4.5CM FROM THE DISTAL TIP AND THE SHEARED SEGMENT IS APPROXIMATELY 1CM IN LENGTH. THE BLACK CATHETER WAS NOTED TO BE KINKED AND THE TIP WAS APPEARED TO BE OUT OF ROUND. THE HUB OF THE BLACK CATHETER WAS MISSING, AND THE FLARE OF THE CATHETER WAS FOLDED INWARD AND OUT OF ROUND. THE TIP OF THE SHEATH APPEARED TO HAVE A SMALL SLICE AROUND THE TAPERED PORTION. THE OUTER DIAMETER OF THE BLACK CATHETER WAS MEASURED TO BE WITHIN THE SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT AND THE RELATED SUBASSEMBLY LOTS REVEALED ONE RELEVANT NONCONFORMANCE, IN WHICH ALL NONCONFORMING PRODUCT WAS SCRAPPED AND 100% INSPECTED PER QC PRIOR TO FURTHER PRODUCTION. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_LABS_REV7] ¿LIVER ACCESS AND BIOPSY SET,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿INSTRUCTIONS FOR USE USING A SELECTIVE CATHETER AND WIRE GUIDE OF CHOICE, CATHETERIZE THE RIGHT HEPATIC VEIN OR AN APPROPRIATE ALTERNATIVE HEPATIC VEIN BRANCH. LEAVE THE WIRE IN A SAFE, DISTAL POSITION, AND REMOVE THE CATHETER. CAUTION: TO PREVENT CARDIAC ARRHYTHMIAS, CONTINUOUS CARDIAC MONITORING IS RECOMMENDED WHILE NEGOTIATING PAST THE RIGHT ATRIUM. INTRODUCE AND ADVANCE THE TRANSJUGULAR INTRODUCER SHEATH AND STIFFENING CANNULA OVER THE WIRE GUIDE INTO THE SELECTIVE HEPATIC VEIN. WHEN INTRODUCING THESE COMPONENTS AS A PREASSEMBLED SET, THE INCLUDED STRAIGHT CATHETER MAY BE USED TO FACILITATE INTRODUCTION. ONCE THE SET IS POSITIONED WITHIN THE HEPATIC VEIN, THE STRAIGHT CATHETER SHOULD BE REMOVED. NOTE: CARE SHOULD BE TAKEN TO PREVENT DAMAGE TO THE STRAIGHT CATHETER DURING REMOVAL THROUGH THE METAL STIFFENING CANNULA. LEAVING A WIRE GUIDE THROUGH THE STRAIGHT CATHETER DURING REMOVAL MAY AID IN PREVENTING CATHETER DAMAGE.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, PRODUCT IFU, AND DEVICE FAILURE ANALYSIS SUGGESTS THAT THE DEVICES WERE NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THE CAUSE OF EVENT TO BE RELATED TO PATIENT CONDITION. IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY, RESULTING IN DIFFICULT ADVANCEMENT WHICH LIKELY CONTRIBUTED TO THE DAMAGE TO THE BLACK CATHETER AND THE SHEATH WHILE BEING ADVANCED WITH THE METAL STIFFENING CANNULA. 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 BLACK CATHETER OF A LIVER ACCESS AND BIOPSY SET TORE. DIFFICULTY WAS EXPERIENCED DURING ADVANCEMENT THROUGH CURVED VASCULATURE INTO THE SUPRA HEPATIC ARTERY. AFTER A FEW ATTEMPTS, IT WAS DISCOVERED THAT THE CATHETER WAS "ATTACHED" TO THE SHEATH AND COULD NOT ADVANCE. THE DEVICE WAS REMOVED AND NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. A PHOTO WAS PROVIDED BY THE CUSTOMER SHOWING A TORN BLACK CATHETER INSIDE THE SHEATH. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
IN ADDITIONAL INFORMATION, IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY AND ADVANCEMENT WAS VERY DIFFICULT.
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 |
|---|---|---|---|---|---|---|---|
| 259268 | LIVER ACCESS AND BIOPSY SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | NA | 15162143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 9FR INTRODUCER (TERUMO)| AMPLATZ SUPERSTIFF GUIDEWIRE 0.035 X180CM(BOSTON) |