ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
Report
- Report Number
- 1820334-2021-01896
- Event Type
- Malfunction
- Date Received
- July 29, 2021
- Date of Event
- May 5, 2021
- Report Date
- August 12, 2022
- Manufacturer
- COOK INC
- Product Code
- FGE
- UDI-DI
- 00827002094970
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: B5. 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: ON 22JUL2021, COOK MEDICAL INC. RECEIVED A COMPLAINT FROM A REPRESENTATIVE AT THE AGILITY LOGISTICS FACILITY LOCATED IN THE CITY OF DORAL, FL. A PROCEDURE WAS BEING PERFORMED ON 05MAY2021 USING A ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER (ULT8.5-38-40-P-32S-CLB-RH, LOT # 10144642), WHEN DIFFICULTY WAS ENCOUNTERED WHILE ATTEMPTING TO WITHDRAW THE SUPPLIED FLEXIBLE STIFFENER FROM THE CATHETER. THIS RESULTED IN THE WRINKLING OF THE CATHETER. ANOTHER BILIARY DRAIN WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION OF PHOTOS PROVIDED BY THE DISTRIBUTOR, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, THE CUSTOMER PROVIDED A PHOTO OF THE COMPLAINT DEVICE THAT SHOWED THE FLEXIBLE STIFFENER REMAINING WITHIN THE MAC-LOC ASSEMBLY/CATHETER LUMEN. 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 DESIGN HISTORY FILES (DHF) CONCLUDED THAT THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 10144642 FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF SUBASSEMBLY LOT SA10073331 FOUND TWO RELATED NONCONFORMANCES; HOWEVER, ALL NONCONFORMING DEVICES WERE SCRAPPED PRIOR TO FURTHER PROCESSING. THE SUPPLIED NYRT-4.3BE-60CM-TUBING-W/HUB-CAP-LABEL, LOT NUMBER 1996007.1, AND THE WCLT-8.5-70CM-WHITE TUBING, LOT NUMBER 1982116.2, ARE SUPPLIED BY COOK POLYMER TECHNOLOGY. THERE WERE NO ABNORMALITIES RECORDED DURING THE INCOMING INSPECTION PROCESS. 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_MULTI_REV5] ¿MULTIPURPOSE DRAINAGE CATHETER,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: ¿WHEN INSERTING A STIFFENING CANNULA INTO A CATHETER WITH RETENTION SUTURE, HOLD SUTURE DURING CANNULA INSERTION TO AVOID BUNCHING OR TANGLING OF SUTURE.¿ INSTRUCTIONS FOR USE: ¿UNDER FLUOROSCOPIC CONTROL, PERFORM STANDARD TECHNIQUES FOR PLACEMENT OF PERCUTANEOUS DRAINING CATHETERS, EITHER BY SELDINGER ACCESS OR TROCAR ACCESS. ONCE CATHETER IS IN DESIRED LOCATION, REMOVE ANY WIRE GUIDES, TROCARS, OR STIFFENERS, ALLOWING THE CATHETER TO FOR ITS CONFIGURATION.¿ 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.¿ UPON A REVIEW OF THE DMR, DHR, DHF AND IFU, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION, OR THAT THERE ARE NONCONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION PHOTOS PROVIDED BY THE CUSTOMER AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD BE ATTRIBUTED TO A MANUFACTURING DEFICIENCY. A PREVIOUS CAPA INVESTIGATION REGARDING DIFFICULT ADVANCEMENT AND REMOVAL OF THE FLEXIBLE STIFFENER WAS PERFORMED AND CONCLUDED THAT THE INNER DIAMETER OF THE CATHETER WAS UNDERSIZED DUE TO THE LACK OF IN-PROCESS INSPECTION DIMENSIONS AND MATERIAL SHRINKAGE. AS SOME OF THE CATHETER TUBING LOTS WERE MANUFACTURED PRIOR TO IMPLEMENTATION ACTIVITIES OF THE CAPA, COOK WILL CONCLUDE WITH FINDINGS OF THE CAPA. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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 ON 10AUG2021: THE DEVICE WAS PLACED IN THE BILIARY WAY OF A BED BOUND PATIENT BY MICROPUNCTURE. THE DEVICE WAS BEING UTILIZED TO PERFORM AN INTERVENTION. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED, AS THE CATHETER INTRODUCING STIFFENING CANNULA BECAME TRAPPED INSIDE OF THE BILIARY DRAIN. ANOTHER BILIARY DRAIN WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADDITIONAL INTERVENTIONS OR PROLONGED HOSPITALIZATION OF THE PATIENT WERE REQUIRED. PATIENT INFORMATION IS UNAVAILABLE.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL PRODUCT CODES: LJE, GBO. (B)(6). OCCUPATION: "PHARMACEUTICAL." 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.
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FOR BILIARY DRAINAGE. WHILE ATTEMPTING TO PLACE THE DRAIN IN THE PATIENT, THE USER EXPERIENCED DIFFICULTY REMOVING THE FLEXIBLE STIFFENER FROM THE CATHETER. WRINKLING OF THE CATHETER "AFTER TRACTION" WAS NOTED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1142326 | ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK INC | N/A | 10144642 | 00827002094970 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |