ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
Report
- Report Number
- 1820334-2022-00648
- Event Type
- Malfunction
- Date Received
- April 25, 2022
- Date of Event
- April 14, 2022
- Report Date
- December 16, 2022
- Manufacturer
- COOK INC
- Product Code
- GBO
- UDI-DI
- 00827002097667
- 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 (B)(6) 2022, COOK MEDICAL INC. RECEIVED A COMPLAINT FROM A REPRESENTATIVE OF RIA ENDOVASCULAR, GREENWOOD VILLAGE CO (UNITED STATES). IT WAS REPORTED THAT, WHEN USING ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETERS (RPN: ULT10.2-38-45-P-6S-CLM-RH; LOT: 14088718) FOR STOMAL BILATERAL URINARY DIVERSION, IT WAS EXTREMELY DIFFICULT TO REMOVE THE FLEXIBLE STIFFENERS FROM THE DRAINS AFTER PLACEMENT. DUE TO THE FRICTION/TENSION RESULTING IN THE STRETCHING OF THE STIFFENERS, THE PHYSICIAN WAS CONCERNED THE DRAINS WERE GOING TO BREAK DUE TO THE FORCE APPLIED. UPON REMOVAL OF THE STIFFENERS, THE DRAINS WERE LEFT SUCCESSFULLY INSIDE THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), 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. 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. A REVIEW OF THE DHR FOR LOT 14088718 RECORDS NO RELEVANT NON-CONFORMANCES. THE DHR FOR SUB-ASSEMBLY LOT, SA13854642, RECORDS ONE POSSIBLE RELEVANT NON-CONFORMANCE FOR "BAD TIP". THIS DEVICE WAS SCRAPPED PRIOR TO FURTHER PROCESSING. TO DATE, A FURTHER SEARCH OF OUR DATABASE RECORDS FOUND THIS TO BE THE ONLY COMPLAINT RECEIVED INVOLVING THE REPORTED LOT NUMBER. SINCE THERE IS OBJECTIVE EVIDENCE THE DHR WAS FULLY EXECUTED, COOK HAS CONCLUDED THERE IS NO EVIDENCE THE DEVICES WERE MANUFACTURED OUT OF SPECIFICATION OR THAT THERE ARE NON-CONFORMING DEVICES 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 PRODUCT, 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.
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 FEMALE PATIENT REQUIRED PLACEMENT OF TWO ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETERS FOR BILATERAL URINARY DIVERSIONS. DURING THE PROCEDURE, THE FLEXIBLE STIFFENERS WERE DIFFICULT TO REMOVE FROM THE CATHETERS AFTER THE DRAINS WERE PLACED. 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.
ADDITIONAL INFORMATION RECEIVED ON 29APR2022 CONFIRMED THAT THE STIFFENERS WERE ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETELY SUCCESSFULLY AND THE DRAINS WERE LEFT IN PLACE AS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170540 | ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER | GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY | GBO | COOK INC | N/A | 14088718 | 00827002097667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | BOSTON SCIENTIFIC ZIP WIRE| TERUMO ADVANTAGE WIRE |