ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE
Report
- Report Number
- 1820334-2024-00735
- Event Type
- Malfunction
- Date Received
- May 30, 2024
- Report Date
- September 25, 2024
- Manufacturer
- COOK INC
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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 OR UNAVAILABLE. G4: PMA/510(K) # - K182985. 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. CORRECTION: B1, H1 - UPON COMPLETION OF THE INVESTIGATION, IT WAS DETERMINED THAT THERE IS EVIDENCE THE COMPLIANT DEVICE¿S PACKAGING WAS SEALED AT ONE TIME. ALTHOUGH THE PACKAGE WAS OPENED, THE SEAL WAS NOT MISSING. PER A SEARCH OF RISK DOCUMENTATION AND PREVIOUS COMPLAINT DATA, THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE FAILURE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF THE FAILURE WERE TO RECUR. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY, AS NO LIFE-THREATENING OR PERMANENTLY IMPAIRING INJURY WAS ALLEGED, NOR WAS INTERVENTION TAKEN AS A RESULT OF THE DEVICE FAILURE WHICH WOULD BE REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION. 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.
AS REPORTED, UPON REMOVING A ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE FROM ITS SHIPPING BOX, THE PEEL-AWAY PACKAGE WAS OPEN. THIS OCCURRED PRIOR TO PATIENT CONTACT.
NO ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1437250 | ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE | DQX WIRE, GUIDE, CATHETER | DQX | COOK INC | 15937221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |