ULTRATHANE COPE NEPHROURETEROSTOMY SET
Report
- Report Number
- 1820334-2020-01390
- Event Type
- Malfunction
- Date Received
- July 30, 2020
- Date of Event
- July 8, 2020
- Report Date
- September 30, 2020
- Manufacturer
- COOK INC
- Product Code
- FAD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. 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.
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 UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. THE GUTHRIE CLINIC IN THE UNITED STATES INFORMED COOK OF AN INCIDENT INVOLVING AN ULTRATHANE COPE NEPHROURETEROSTOMY SET. THIS INSTANCE OCCURRED ON (B)(6) 2020 FOR A NEPHROURETERAL STENT EXCHANGE. THE STIFFENER COULD NOT BE REMOVED FROM THE CATHETER ONCE THE CATHETER WAS IN PLACE. AFTER THE DEVICE WAS REMOVED FROM THE PATIENT THE PHYSICIAN MANIPULATED THE DEVICE TO DETERMINE THE ISSUE. IN THE PROCESS, THE STIFFENER SEPARATED IN HALF. THIS DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY, THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT RETURNED ONE 8.5FR CATHETER WITH THE BLUE STIFFENER SEPARATED AND STUCK INSIDE THE CATHETER. APPROXIMATELY 21CMOF ELONGATED SECTION OF THE BLUE STIFFENER WAS ALSO RETURNED. THE OUTER DIAMETER OF THE STIFFENER AND THE INNER DIAMETER OF THE CATHETER WERE MEASURED TO BE WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. PRODUCT LABELING WAS ALSO REVIEWED. INSTRUCTIONS FOR USE ARE PACKAGED WITH THIS DEVICE. RELEVANT SECTIONS INCLUDE: 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. 5. OVER THE WIRE GUIDE, INTRODUCE THE STENT/STIFFENING CANNULA INTO THE KIDNEY COLLECTING SYSTEM. 6. 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. 7. REMOVE THE STIFFENING CANNULA FROM THE STENT, LEAVING THE WIRE GUIDE IN PLACE.¿. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION. THE DHR FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS RECORDS NO RELATED NONCONFORMANCES. A DATABASE SEARCH WAS COMPLETED ON THE COMPLAINT LOT AND NO ADDITIONAL COMPLAINTS WERE FOUND. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, NO RELATED NON-CONFORMANCES AND NO ADDITIONAL COMPLAINTS FROM THE SAME LOT, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE AND IS CURRENTLY UNDERGOING INVESTIGATION. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION PROVIDED 03SEP2020 INDICATED THAT THE DEVICE WAS REMOVED FROM THE PATIENT PRIOR TO SEPARATION. THE STIFFENER WAS DIFFICULT TO REMOVE FROM THE CATHETER, SO THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND MANIPULATED THE DEVICE IN AN ATTEMPT TO DETERMINE THE ISSUE.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(6). 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 A (B)(6) FEMALE PATIENT REQUIRED AN ULTRATHANE COPE NEPHROURETEROSTOMY SET FOR A NEPHRO-URETERAL TUBE EXCHANGE. THE DEVICE WAS PLACED USING AN OVER THE WIRE EXCHANGE TECHNIQUE. THE OPERATOR REPORTED, UPON REMOVAL OF THE STIFFENING CANNULA RESISTANCE WAS FELT AND THE DEVICE "SNAPPED IN HALF" WITHIN THE CATHETER. 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 |
|---|---|---|---|---|---|---|---|
| 810716 | ULTRATHANE COPE NEPHROURETEROSTOMY SET | FAD STENT, URETERAL | FAD | COOK INC | N/A | 10288334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |