LIVER ACCESS AND BIOPSY SET
Report
- Report Number
- 1820334-2023-00600
- Event Type
- Malfunction
- Date Received
- May 15, 2023
- Date of Event
- May 8, 2023
- Report Date
- November 16, 2023
- Manufacturer
- COOK INC
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL REPORTER- CUSTOMER (PERSON): PHONE: (B)(6). INTIAL REPORTER OCCUPATION: RTR (VI). 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 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE 5 FRENCH CATHETER IN A LIVER ACCESS AND BIOPSY SET SEPARATED. DURING A PROCEDURE, THE HUB OF THE 5 FRENCH BLACK CATHETER SEPARATED FROM THE SHAFT DURING REMOVAL FROM THE 7 FRENCH ACCESS SHEATH. THE PATIENT WAS UNHARMED, AND THE PROCEDURE CONTINUED. 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, AND INSTRUCTIONS FOR USE (IFU) OF THE COMPLAINT DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, 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 NO RELEVANT NON-CONFORMANCES. THERE IS ONE ADDITIONAL COMPLAINT ON THIS LOT WHICH WAS DETERMINED TO BE FOR THE SAME DEVICE OF THIS COMPLAINT BUT FOR AN UNRELATED FAILURE. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [T_LABS2_REV1] ¿LIVER ACCESS AND BIOPSY SET,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿WARNINGS: EXTREME CARE MUST BE EXERCISED DURING MANIPULATION AND WITHDRAWAL OF CATHETER TO PREVENT PULLING CATHETER APART. INSERTION THROUGH A SYNTHETIC VASCULAR GRAFT SHOULD BE AVOIDED WHENEVER POSSIBLE. 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 (IF APPLICABLE) 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. HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND 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.¿ THE INFORMATION GATHERED FROM THE DMR, DHR, AND CURRENT PRODUCT IFU INDICATES THE COMPLAINT DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION. COOK DID NOT IDENTIFY ANY NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THE CAUSE OF EVENT TO BE COMPONENT FAILURE UNRELATED TO ANY MANUFACTURING OR DESIGN DEFICIENCIES. IT¿S POSSIBLE THE CATHETER WAS PULLED BY THE HUB DURING REMOVAL, RESULTING IN THE SEPARATION, 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.
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.
IT WAS REPORTED THAT THE 5 FRENCH CATHETER IN A LIVER ACCESS AND BIOPSY SET SEPARATED. DURING A PROCEDURE, THE HUB OF THE 5 FRENCH BLACK CATHETER SEPARATED FROM THE SHAFT DURING REMOVAL FROM THE 7 FRENCH ACCESS SHEATH. THE PATIENT WAS UNHARMED, AND THE PROCEDURE CONTINUED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
PER ADDITIONAL INFORMATION WAS PROVIDED ON 15MAY2023, THE PROCEDURE BEING PERFORMED ON THE PATIENT WAS A TRANSJUGULAR LIVER BIOPSY. THE DEVICE WAS CONFIRMED TO BE "OK" WHEN REMOVED FROM THE PACKAGE FOR THE PROCEDURE. THE END OF THE 5 FRENCH BLACK CATHETER AND THE OUTER AREA OF THE 7 FRENCH ACCESS SHEATH WERE OBSERVED TO BE SHEARED AFTER THE HUB OF THE 5 FRENCH BLACK CATHETER SEPARATED. IT WAS ALSO NOTED THAT NO PORTION OF THE SEPARATED CATHETER IN THE BODY OF THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1651157 | LIVER ACCESS AND BIOPSY SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | N/A | 14793425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |