LIVER ACCESS AND BIOPSY SET
Report
- Report Number
- 1820334-2022-00121
- Event Type
- Injury
- Date Received
- January 27, 2022
- Date of Event
- January 14, 2022
- Report Date
- January 26, 2023
- Manufacturer
- COOK INC
- Product Code
- DYB
- UDI-DI
- 00827002574854
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AGE AT THE TIME OF EVENT: AGE: "MID 80S". INITIAL REPORTER OCCUPATION: INTERVENTION RADIOLOGIST. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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 UNCHANGED, UNKNOWN, OR UNAVAILABLE. CORRECTION: H6 (ANNEX A AND ANNEX G) INVESTIGATION ¿ EVALUATION GREAT LAKES MEDICAL IMAGING (UNITED STATES) INFORMED COOK ON (B)(6) 2022 OF AN INCIDENT INVOLVING A LIVER ACCESS AND BIOPSY SET (RPN: LABS-100-J-01) FROM LOT 13124124. WHILE PERFORMING A TRANSJUGULAR LIVER BIOPSY THE DOCTOR ADVANCED A 7FR LABS SHEATH WITH A 5FR HYDROPHILIC CATHETER PLACED INSIDE IT OVER THE WIRE GUIDE INTO THE HEPATIC VEIN. WHEN THE TIP OF THE 7FR SHEATH WAS IN THE CORRECT LOCATION THE DOCTOR WANTED TO REMOVE THE 5FR CATHETER AND WIRE GUIDE BUT ENCOUNTERED RESISTANCE. THE RESISTANCE THEN RELEASED, AND UPON REMOVAL IT WAS DISCOVERED THAT APPROXIMATELY 2CM OF THE 5FR CATHETER HAD TORN OFF. THE TIP WAS VISUALIZED WITHIN THE LUMEN OF THE HEPATIC VEIN. AFTER THE BIOPSY WAS PERFORMED THE DOCTOR ATTEMPTED TO RETRIEVE THE PIECE. AFTER A FEW UNSUCCESSFUL ATTEMPTS THE PIECE BECAME DISLODGED AND COULD NO LONGER BE VISUALIZED. POST PROCEDURE X-RAYS WERE PERFORMED, AND THE PIECE OF THE CATHETER WAS VISUALIZED IN A TERMINATING PORTION OF THE RIGHT PULMONARY ARTERY. THE PATIENT WAS INFORMED BY THE DOCTOR OF THE EVENT AND THE PATIENT FOLLOWED UP WITH THEIR PRIMARY CARE PHYSICIAN ON ANY FURTHER PROCEDURES. FURTHER COMMUNICATION WITH THE CUSTOMER REVEALED THAT THE PATIENT RETURNED TO THE HOSPITAL AND THE CATHETER FRAGMENT WAS SUCCESSFULLY RETRIEVED IN AN ADDITIONAL PROCEDURE. NO OTHER ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED FOR THIS INCIDENT. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE CATHETER FROM A LIVER ACCESS AND BIOPSY SET WAS RECEIVED IN A USED CONDITION. THE CATHETER WAS TORN 59.5 CM FROM THE WHITE CAP. THE COMPLAINT FAILURE MODE WAS CONFIRMED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE HISTORY RECORD (DHR) FOR LOT 13124124 AND THE TEFLON ANGIOGRAPHIC CATHETER SUBASSEMBLY LOTS (IC13064923 AND IC13106020) REVEALED TWO RELEVANT NONCONFORMANCES. THE FIRST NONCONFORMANCE IS FOR SURFACE DEFECT ON FOUR DEVICES AND THE SECOND NONCONFORMANCE IS FOR SHAFT DAMAGED ON FIVE DEVICES. ALL NONCONFORMING DEVICES WERE SCRAPPED. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE DEVICE LOT OR ANY OTHER LOT USING THESE SUBASSEMBLIES. 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: ¿3. INTRODUCE AND ADVANCE THE TRANSJUGULAR 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.¿ FROM THE INFORMATION PROVIDED UPON REVIEW OF THE CUSTOMER TESTIMONY, DMR, DHR, IFU, AND INSPECTION OF RETURNED DEVICE, COOK CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. COOK COULD CONFIRM THAT THERE WERE 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 HAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. 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 5FR CATHETER INCLUDED IN THE LIVER ACCESS AND BIOPSY SET SHEARED OFF DURING A TRANSJUGULAR LIVER BIOPSY PROCEDURE AND REMAINED INSIDE THE PATIENT'S PULMONARY ARTERY. THE PHYSICIAN GAINED ACCESS TO THE HEPATIC VEIN USING AN MPB CATHETER AND BENTSON WIRE. THE BENTSON WIRE WAS THEN EXCHANGED FOR AN AMPLATZ EXTRA STIFF WIRE FOR STABILITY AND THE 7FR SHEATH WITH THE 5FR HYDROPHILIC CATHETER WAS ADVANCED OVER THE WIRE. FOLLOWING PLACEMENT IN THE TARGET LOCATION, AN ATTEMPT WAS MADE TO REMOVE THE 5FR CATHETER IN ORDER TO PREPARE FOR THE BIOPSY DEVICE. RESISTANCE WAS EXPERIENCED AND THEN SUBSIDED. UPON DEVICE REMOVAL, IT WAS DISCOVERED THAT 2 CM OF THE DISTAL PORTION OF THE 5FR CATHETER HAD SHEARED OFF. THE CATHETER TIP WAS VISUALIZED WITHIN THE LUMEN OF THE HEPATIC VEIN. AFTER THE BIOPSY WAS COMPLETED, RETRIEVAL OF THE FOREIGN BODY WAS ATTEMPTED. AFTER A COUPLE OF ATTEMPTS WITH A SNARE, THE CATHETER PIECE WAS DISLODGED AND COULD NO LONGER BE VISUALIZED. POST PROCEDURE X-RAYS WERE PERFORMED AND THE CATHETER TIP WAS VISUALIZED IN A TERMINATING PORTION OF THE RIGHT PULMONARY ARTERY. THE PHYSICIAN DISCUSSED THE ISSUE WITH THE PATIENT AND WILL FOLLOW UP WITH THE PATIENT'S PRIMARY CARE PHYSICIAN FOR NEXT STEPS, IF ANY. THE PATIENT WAS IDENTIFIED AS A WHITE MALE IN HIS MID-(B)(6). THE PATIENT'S CURRENTS STATUS IS REPORTED TO BE "STABLE." ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 022, IT WAS REPORTED THAT THE WIRE AND CATHETER WERE REMOVED SIMULTANEOUSLY DURING THE INITIAL PROCEDURE. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO SUCCESSFULLY REMOVE THE SHEARED PORTION OF THE 5FR STRAIGHT BLACK CATHETER FROM THE PULMONARY ARTERY. THE PATIENT WAS ASYMPTOMATIC PRIOR TO RETRIEVAL.
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 |
|---|---|---|---|---|---|---|---|
| 297460 | LIVER ACCESS AND BIOPSY SET | DYB INTRODUCER, CATHETER | DYB | COOK INC | N/A | 13124124 | 00827002574854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention| O | BENTSON WIRE| COOK THSF-35-180-AES |