ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
Report
- Report Number
- 1820334-2024-00234
- Event Type
- Injury
- Date Received
- February 19, 2024
- Date of Event
- February 8, 2024
- Report Date
- May 7, 2024
- Manufacturer
- COOK INC
- Product Code
- FGE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2A - COMMON DEVICE NAME: ADDITIONAL NAMES: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D2B - PROCODE: ADDITIONAL PRODUCT CODES: GBO, LJE. E1 - CUSTOMER(PERSON): POSTAL CODE: (B)(6); MOBILE: (B)(6). E3 - OCCUPATION: RADIOLOGIST. G4 ¿ PMA/510(K) #: K173035. 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, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. IT WAS REPORTED THAT THE FLEXIBLE STIFFENING CANNULA OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS DIFFICULT TO REMOVE AND SEPARATED. DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) PROCEDURE, THE STIFFENING CANNULA WAS DIFFICULT TO WITHDRAW. THE CANNULA SEPARATED AND SOME PORTION REMAINED INSIDE THE CATHETER THAT WAS PLACED IN THE PATIENT. A FEW WEEKS LATER, THE CATHETER WITH THE RETAINED STIFFENER WAS REMOVED AND A NEW 10.2 FRENCH CATHETER WAS PLACED. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. 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 DEVICE HISTORY RECORD (DHR) FOR THE DEVICE AND SUBASSEMBLY LOTS FOUND TWO RELEVANT NONCONFORMANCES, IN WHICH THE DEVICES WERE SCRAPPED PRIOR TO FURTHER PROCESSING. 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_MULTI2_REV1] ¿MULTIPURPOSE DRAINAGE CATHETER,¿ STATES: "PRECAUTIONS: WHEN INSERTING A STIFFENING CANNULA INTO A CATHETER WITH RETENTION SUTURE, HOLD SUTURE DURING CANNULA INSERTION TO AVOID BUNCHING OR TANGLING OF SUTURE. A TFE-COATED WIRE GUIDE MUST BE USED WITH ULTRATHANE CATHETERS. HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR 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.¿ EVIDENCE PROVIDED UPON REVIEW OF DMR, DHR, AND IFU SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT. 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.
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.
IT WAS REPORTED THAT THE FLEXIBLE STIFFENING CANNULA OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER SEPARATED AND WAS DIFFICULT TO REMOVE. DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE(PTBD) PROCEDURE, THE STIFFENING CANNULA WAS DIFFICULT TO WITHDRAW. THE CANNULA SEPARATED AND SOME PORTION REMAINED INSIDE THE PATIENT. ANOTHER PROCEDURE WILL BE REQUIRED TO REMOVE THE REMAINING PORTION OF THE DEVICE FROM THE PATIENT'S BODY. 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 PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN ADDITIONAL INFORMATION RECEIVED 01APR2024, IT WAS REPORTED THAT THE CATHETER DID NOT SEPARATE. A PORTION OF THE STIFFENING CANNULA SEPARATED AND WAS RETAINED WITHIN THE CATHETER; THE CATHETER REMAINED IN THE PATIENT. A FEW WEEKS LATER, THE 8.5 FR CATHETER WITH THE RETAINED PORTION OF THE STIFFENING CANNULA WAS REMOVED, AND IT WAS REPLACED WITH A NEW 10.2 FR CATHETER. A CUSTOMER PROVIDED VIDEO OF THE COMPLAINT DOES SHOW DIFFICULT REMOVAL OF THE STIFFENING CANNULA FROM THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 529336 | ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK INC | N/A | 15454644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Required Intervention |