ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
Report
- Report Number
- 1820334-2022-00649
- Event Type
- Malfunction
- Date Received
- April 25, 2022
- Report Date
- December 19, 2022
- Manufacturer
- COOK INC
- Product Code
- GBO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL REPORTER OCCUPATION: IR LEAD TECH. PMA/510(K) #: EXEMPT. 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 UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: ON 14APR2022, COOK MEDICAL INC. RECEIVED A COMPLAINT FROM A REPRESENTATIVE OF RIA ENDOVASCULAR, GREENWOOD VILLAGE CO (UNITED STATES) REGARDING AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER (RPN: ULT10.2-38-45-P-6S-CLM-RH; LOT: UNKNOWN). THE DIFFICULTY OCCURRED WHEN THE ATTENDING PHYSICIAN WAS ATTEMPTING TO REMOVE THE FLEXIBLE STIFFENER FROM THE DRAIN. EXCESSIVE FORCE WAS APPLIED TO THE POINT WHERE THE PHYSICIAN BELIEVED THE DRAIN WAS GOING TO BREAK DUE TO THE FORCE APPLIED. EVENTUALLY, THE STIFFENER WAS REMOVED AND THE DRAIN WAS LEFT IN PLACE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES, AND SPECIFICATIONS OF THE 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 SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO IDENTIFY THE COMPLAINT LOT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. BASED ON THIS INFORMATION, THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK REVIEWED THE 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. 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.¿ BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCTS, AND THE RESULTS OF THE INVESTIGATION, COOK DETERMINED THE ROOT CAUSE CATEGORY WOULD FALL UNDER CAUSE TRACED TO COMPONENT FAILURE, BEING DEFINED AS COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING DEFICIENCIES. 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.
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. 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.
IT WAS REPORTED THAT A PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR A CATHETER EXCHANGE PROCEDURE. DURING THE PROCEDURE, THE FLEXIBLE STIFFENER WAS DIFFICULT TO REMOVE FROM THE CATHETER. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION RECEIVED ON 29APR2022 CONFIRMED THAT THE STIFFENER WAS ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETELY SUCCESSFULLY AND THE DRAIN WAS LEFT IN PLACE AS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 982784 | ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER | GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY | GBO | COOK INC | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |