LIVER ACCESS AND BIOPSY SET
Report
- Report Number
- 1820334-2024-00814
- Event Type
- Injury
- Date Received
- June 14, 2024
- Report Date
- September 9, 2024
- Manufacturer
- COOK INC
- Product Code
- DYB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5. CORRECTION: D4 - MODEL #, H6 - ANNEX F. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D2, 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.
CORRECTION: H6 - ANNEX G. ADDITIONAL INFORMATION: B3 - DATE OF EVENT IS AN UNKNOWN DATE IN (B)(6) 2023. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT A LIVER ACCESS AND BIOPSY SET WAS REQUIRED FOR A TRANSJUGULAR LIVER BIOPSY PROCEDURE. DURING THE PROCEDURE, THE INTRODUCER WAS ADVANCED IN THE UPPER RIGHT HEPATIC VEIN. AT SOME POINT DURING THE PROCEDURE, AN UNKNOWN FRAGMENTATION OCCURRED THAT WAS NOT VISIBLE DUE TO THE "RADIOTRANPARENCY" OF THE INTRODUCER THAT REMAINED IN THE SUPRAHEPATIC VEIN. NO DIFFICULTIES WERE NOTED DURING THE PROCEDURE. A COMPUTED TOMOGRAPHY SCAN ("TAC") WAS PERFORMED A YEAR LATER AND REVEALED A FOREIGN BODY IN THE UPPER HEPATIC VEIN. THE PHYSICIAN SUSPECTS THAT THE FOREIGN BODY IS A PIECE OF CATHETER OR INTRODUCER. IT WAS NOTED THAT THE FOREIGN BODY FACES TOWARDS THE PORTAL VEIN, WHILE THE BIOPSY AND PUNCTURE (AS SHOWN IN A PROVIDED VIDEO) WAS IN THE DIRECTION OF THE RIBS. A WIRE GUIDE WAS ALSO USED DURING THE PROCEDURE. THERE ARE NO INTENTIONS TO REMOVE THE FOREIGN BODY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF QUALITY CONTROL, AND INSTRUCTIONS FOR USE (IFU), AS WELL AS INSPECTION OF THE CUSTOMER PROVIDED PHOTOS AND VIDEO WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, PHOTOS AND A VIDEO WERE PROVIDED BY THE CUSTOMER. THE IMAGING AND VIDEO SHOW A FRAGMENT INSIDE THE PATIENT'S BODY; HOWEVER, IDENTITY OF THE FRAGMENT IS UNCLEAR. 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 DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. AN EXPANDED SALES SEARCH TO THE CUSTOMER WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU, [T_LABS_REV7] ¿LIVER ACCESS AND BIOPSY SET, PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: "INSTRUCTIONS FOR USE -INTRODUCE AND ADVANCE THE TRANSJUGULAR INTRODUCER SHEATH AND STIFFENING CANNULA OVER THE WIRE GUIDE INTO THE SELECTED 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." BASED ON THE INFORMATION PROVIDED, THE PROVIDED PHOTOS AND VIDEO, THE RESULTS OF THE INVESTIGATION, AND PREVIOUSLY REPORTED COMPLAINTS, COOK PRESUMES THE DEVICE THAT EXPERIENCED THIS FAILURE IS THE STRAIGHT CATHETER. COOK CONCLUDED THE CAUSE OF EVENT TO BE COMPONENT FAILURE UNRELATED TO ANY MANUFACTURING OR DESIGN DEFICIENCIES. IT IS POSSIBLE THAT THE CATHETER WAS BEING WITHDRAWN THROUGH THE METAL CANNULA, RESULTING IN THE CATHETER SHEARING AND SEPARATING. HOWEVER, THIS CANNOT BE CONFIRMED WITHOUT ADDITIONAL INFORMATION. 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.
ADDITIONAL INFORMATION WAS RECEIVED ON 01AUG2024. ACCORDING TO THE PHYSICIAN, THE NOTED FOREIGN BODY IS THOUGHT TO BE A PORTION OF A CATHETER OR INTRODUCER THAT WOULD HAVE BEEN USED IN A PROCEDURE APPROXIMATELY ONE YEAR AGO. AS SHOWN IN THE VIDEO PROVIDED BY THE CUSTOMER, THE FOREIGN BODY WAS LOCATED TOWARDS THE PORTAL VEIN, WHILE THE BIOPSY AND PUNCTURE WERE IN THE DIRECTION OF THE RIBS. AT PRESENT, THE PATIENT HAS NOT REPORTED ANY ADVERSE EFFECTS AND THERE ARE NO PLANS TO REMOVE THE FOREIGN BODY.
IT WAS REPORTED THAT A LIVER ACCESS AND BIOPSY SET WAS REQUIRED FOR A TRANSJUGULAR LIVER BIOPSY PROCEDURE. DURING THE PROCEDURE, THE INTRODUCER WAS ADVANCED IN THE THE UPPER RIGHT HEPATIC VEIN. AT SOME POINT DURING THE PROCEDURE, AN UNKNOWN FRAGMENTATION OCCURRED THAT WAS NOT VISIBLE DUE TO THE "RADIOTRANPARENCY" OF THE INTRODUCER THAT REMAINED IN THE SUPRAHEPATIC VEIN. A COMPUTED TOMOGRAPHY SCAN ("TAC") WAS PERFORMED A YEAR LATER AND REVEALED A FOREIGN BODY IN THE UPPER HEPATIC VEIN. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
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 |
|---|---|---|---|---|---|---|---|
| 372710 | LIVER ACCESS AND BIOPSY SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | G50780 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |