LIVER ACCESS AND BIOPSY SET
Report
- Report Number
- 1820334-2024-00952
- Event Type
- Malfunction
- Date Received
- July 15, 2024
- Date of Event
- July 5, 2024
- Report Date
- October 3, 2024
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002507807
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. 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.
D2 AND 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 E1 - CUSTOMER (PERSON): POSTAL CODE: (B)(6); PHONE NUMBER: (B)(6) E3 - OCCUPATION:(B)(6) 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 IT WAS REPORTED THAT THE HUB OF THE 5 FRENCH CATHETER DETACHED DURING A LIVER BIOPSY PROCEDURE. THE INTRODUCER SHEATH WAS FLUSHED, THE 5 FRENCH BLACK CATHETER WAS INSERTED INTO THE INTRODUCER, AND THE COMPONENTS WERE ADVANCED OVER AN UNKNOWN BENSTON WIRE GUIDE INTO THE PATIENT. WHEN THE PHYSICIAN TRIED TO REMOVE THE CATHETER, THE HUB BROKE OFF. THE USE OF FORCEPS WAS NEEDED TO REMOVE THE CATHETER. THE BIOPSY SET WAS STILL USED TO INSERT THE INTRODUCER WITHOUT THE CATHETER, AND THE BIOPSY WAS PERFORMED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE (IFU), AS WELL AS VISUAL INSPECTION OF THE RETURNED PRODUCT, WERE CONDUCTED DURING THE INVESTIGATION. TWO UNUSED/SEALED SETS WERE RECEIVED. UPON OPENING THESE SETS, NO DAMAGE WAS NOTED TO ANY OF THE COMPONENTS. THE OPENED COMPLAINT DEVICE WAS NOT RETURNED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT CONTROLS INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. 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: ¿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 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.¿ EVIDENCE GATHERED UPON REVIEW OF THE DMR, PRODUCT IFU, AND DHR, THERE IS NO INDICATION THAT THE COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK DID NOT IDENTIFY ANY NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. IT¿S POSSIBLE THAT AS THE CATHETER WAS BEING REMOVED, IT WAS PULLED BY THE HUB RESULTING IN THE SEPARATION. COOK CANNOT CONFIRM THIS WITHOUT ADDITIONAL INFORMATION. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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. IT WAS CONFIRMED THAT THE STRAIGHT 5 FRENCH BLACK CATHETER EXPERIENCED THE REPORTED FAILURE. NO DIFFICULTY ADVANCING THE CATHETER OVER THE WIRE GUIDE WAS NOTED.
IT WAS REPORTED THAT THE HUB OF THE 5 FRENCH CATHETER DETACHED. DURING A LIVER BIOPSY PROCEDURE, THE INTRODUCER SHEATH WAS FLUSHED, THE 5 FRENCH CATHETER WAS INSERTED INTO THE INTRODUCER, AND THE COMPONENTS WERE ADVANCED OVER AN UNKNOWN BENSTON WIRE GUIDE INTO THE PATIENT. WHEN THE PHYSICIAN TRIED TO REMOVE THE CATHETER, THE HUB BROKE OFF. THE USE OF FORCEPS WAS NEEDED TO REMOVE THE CATHETER. THE BIOPSY SET WAS STILL USED TO INSERT THE INTRODUCER WITHOUT THE CATHETER, AND THE BIOPSY WAS PERFORMED. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2504850 | LIVER ACCESS AND BIOPSY SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | G50780 | 15925469 | 00827002507807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | BENSON WIRE 180 CM.| COOK .035 BENSON WIRE 180CM. |