ULTRATHANE COPE NEPHROURETEROSTOMY SET
Report
- Report Number
- 1820334-2021-02351
- Event Type
- Malfunction
- Date Received
- October 19, 2021
- Date of Event
- October 6, 2021
- Report Date
- August 25, 2022
- Manufacturer
- COOK INC
- Product Code
- FAD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION: D4 - LOT NUMBER, H4, H6 - ANNEX G. 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: ON 06OCT2021, COOK MEDICAL INC. RECEIVED A COMPLAINT FROM A REPRESENTATIVE AT THE MEDSTAR-GEORGETOWN MC (MGMC) IN WASHINGTON DC. IT WAS REPORTED THAT THE SUPPLIED BLUE FLEXIBLE STIFFENER TO THE ULTRATHANE COPE NEPHROURETEROSTOMY SET (RPN: ULT8.5-8.5-22-NUCL-B-RH, LOT #: 13320926) BECAME STUCK AND SHEARED OFF INSIDE THE CATHETER. THE TUBE WAS CUT, AND A WIRE WAS PLACED TO REMOVE THE TUBE. THE SHEARED CATHETER PORTION WAS ABLE TO BE REMOVED COMPLETELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE EFFECTS EXPERIENCED BY THE PATIENT. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO PHYSICAL EXAMINATION COULD BE PERFORMED. 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 LOT 13320926, CATHETER SUB-ASSEMBLY LOTS (SA13302636 AND SA13288799), THE RADIOPAQUE BAND TUBING LOTS (SA13254825 AND SA13254823) AND THE CATHETER TUBING RAW MATERIAL LOT (2033290.2 AND 2028056.2) FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE CERTIFICATE OF COMPLIANCES FOR THE CATHETER TUBING (J11460934130 AND J9817688964) SHOWS THESE LOTS WERE MANUFACTURED ON 05MAR2020 AND 18FEB2020. ADDITIONALLY, THE WCLT-8.5-70CM-WHITE TUBING IS SUPPLIED BY COOK POLYMER TECHNOLOGY (CPT). THERE WERE NO ABNORMALITIES RECORDED DURING THE INCOMING INSPECTION PROCESS. IT SHOULD BE NOTED THAT THERE WERE NO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, T_NUCL_REV4, PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: PRECAUTIONS: "ACTIVATE HYDROPHILIC COATING, IF PRESENT, BY WETTING SURFACE OF DEVICE WITH STERILE WATER OR SALINE. FOR BEST RESULTS, MAINTAIN WETTED CONDITION OF DEVICE DURING PLACEMENT." INSTRUCTIONS FOR USE: STENT PLACEMENT. 1. USING STANDARD PERCUTANEOUS ACCESS TECHNIQUE, ESTABLISH WIRE GUIDE POSITION WELL INTO THE BLADDER. 2. OVER THE WIRE GUIDE, INTRODUCE THE STENT/STIFFENING CANNULA INTO THE KIDNEY COLLECTING SYSTEM. 3. AFTER ESTABLISHING PROPER PROXIMAL AND DISTAL POSITION, PUSH THE STENT OFF THE STIFFENING CANNULA OVER THE WIRE, MAKING SURE THE DISTAL PIGTAIL FORMS WITHIN THE BLADDER. 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 OUR INVESTIGATION, IT WAS CONCLUDED THAT A SUPPLIER MANUFACTURING DEFICIENCY CONTRIBUTED TO THE REPORTED EVENT. A CAPA WAS PREVIOUSLY OPENED TO ADDRESS THE ISSUE OF DIFFICULT ADVANCEMENT AND REMOVAL OF THE FLEXIBLE STIFFENER AND CONCLUDED THAT THE INNER DIAMETER OF THE CATHETER WAS UNDERSIZED DUE TO AN ISSUE WITH SUPPLIER SPECIFICATIONS. BOTH LOTS TO THE CATHETER TUBING WERE CONFIRMED TO HAVE BEEN MANUFACTURED PRIOR TO IMPLEMENTATION ACTIVITIES OF THE CAPA ON 20APR2020. 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.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. OCCUPATION: UNKNOWN. PMA/510(K) #: K171603. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THAT THE BLUE INNER STIFFENER OF AN ULTRATHANE COPE NEPHROURETEROSTOMY SET CATHETER BECAME STUCK AND SHEARED OFF INSIDE OF THE TUBE DURING A PROCEDURE ON AN UNKNOWN PATIENT. THE TUBE WAS THEN CUT AND THE WIRE WAS PLACED IN ORDER TO REMOVE THE TUBE FROM THE PATIENT. THE SHEARED PORTION OF THE STIFFENER WITHIN THE CATHETER TUBE, WAS COMPLETELY REMOVED. NO OTHER ISSUES WERE NOTED DURING THE REMAINDER OF THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAVE BEEN REQUESTED, BUT ARE CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1557262 | ULTRATHANE COPE NEPHROURETEROSTOMY SET | FAD STENT, URETERAL | FAD | COOK INC | N/A | 13320926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |