ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
Report
- Report Number
- 1820334-2024-01611
- Event Type
- Malfunction
- Date Received
- December 6, 2024
- Report Date
- May 30, 2025
- Manufacturer
- COOK INC
- Product Code
- DQX
- 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, 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 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.
E3: OCCUPATION = MANAGER. G4: PMA/510(K) NUMBER = EITHER K110009 OR K130766. 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 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.
SUMMARY OF EVENT: AS REPORTED, DURING UNKNOWN PROCEDURES, A "BROWN SUBSTANCE" HAS BEEN NOTED WHEN ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES HAVE BEEN WIPED DOWN WITH EITHER SALINE OR HEPARINIZED SALINE SOAKED 4X4 GAUZE. PER THE REPORTER, THE WIRES ARE CONTINUOUSLY "STICKY" AND GET STUCK IN CATHETERS. WHEN THE WIRES BECOME STICKY, THEY ARE WIPED WITH THE GAUZE, AND UPON WIPING, A "BROWN SUBSTANCE" IS NOTED ON THE GAUZE. PER THE REPORTER, THE WIRE GUIDES HAVE BEEN USED TO COMPLETE THE PROCEDURES, BUT WITH DIFFICULTY AND FRUSTRATION DUE TO THE WIRES GETTING STICKY AND THEN STUCK IN THE CATHETERS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE ANY PATIENT¿S BODY. THE PATIENT(S) DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE EVENTS. ADDITIONAL INFORMATION WAS RECEIVED ON 09DEC2024. THE EVENTS OCCURRED "OVER THE LAST FEW MONTHS". NON-LATEX, POWDERLESS GLOVES WERE WORN. THE COATING WAS INITIALLY ACTIVATED WITH NORMAL SALINE, AND THE DEVICES WERE FLUSHED PRIOR TO BEGINNING THE PROCEDURE. IT IS UNKNOWN HOW MANY TIMES EACH WIRE WAS USED; HOWEVER, THE WIRES WERE KEPT HYDRATED IN A "FLUSH BOWL" WHEN NOT IN USE. THE "BROWN SUBSTANCE" WAS DESCRIBED AS A BROWN "FILM". INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) OR COMPLAINT HISTORY DUE TO THE LACK OF A LOT NUMBER FROM THE USER FACILITY. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU, SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE THAT THERE ARE NON-CONFORMING DEVICES IN HOUSE OR OUT IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE, UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES, CONTRIBUTED TO THIS INCIDENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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 09DEC2024. THE EVENTS OCCURRED "OVER THE LAST FEW MONTHS". NON-LATEX, POWERLESS GLOVES WERE WORN. THE COATING WAS INITIALLY ACTIVATED WITH NORMAL SALINE, AND THE DEVICES WERE FLUSHED PRIOR TO BEGINNING THE PROCEDURE. IT IS UNKNOWN HOW MANY TIMES EACH WIRE WAS USED; HOWEVER, THE WIRES WERE KEPT HYDRATED IN A "FLUSH BOWL" WHEN NOT IN USE. THE "BROWN SUBSTANCE" WAS DESCRIBED AS A BROWN "FILM".
AS REPORTED, DURING UNKNOWN PROCEDURES, A "BROWN SUBSTANCE" HAS BEEN NOTED WHEN ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDES HAVE BEEN WIPED DOWN WITH EITHER SALINE OR HEPARINIZED SALINE SOAKED 4X4 GAUZE. PER THE REPORTER, THE WIRES ARE CONTINUOUSLY "STICKY" AND GET STUCK IN CATHETERS. WHEN THE WIRES BECOME STICKY, THEY ARE WIPED WITH THE GAUZE, AND UPON WIPING, A "BROWN SUBSTANCE" IS NOTED ON THE GAUZE. PER THE REPORTER, THE WIRE GUIDES HAVE BEEN USED TO COMPLETE THE PROCEDURES, BUT WITH DIFFICULTY AND FRUSTRATION DUE TO THE WIRES GETTING STICKY AND THEN STUCK IN THE CATHETERS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE ANY PATIENT¿S BODY. THE PATIENT(S) DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2119992 | ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |