FDA Adverse Event Injury Summary report: N

HIWIRE NITINOL HYDROPHILIC WIRE GUIDE

MDR report key: 13560999 · Received February 18, 2022

Report

Report Number: 1820334-2022-00261
Event Type: Injury
Date Received: February 18, 2022
Date of Event: February 8, 2022
Report Date: June 1, 2022
Manufacturer: COOK INC
Product Code: OCY
PMA / PMN Number: K082536
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

PROCODE: MJG, INITIAL REPORTER OCCUPATION: UROLOGIST, 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.

Additional Manufacturer Narrative · 0

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS 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.

Additional Manufacturer Narrative · 0

CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803. AS SUCH, THIS EVENT NO LONGER MEETS THE SET CRITERIA FOR A REPORTABLE EVENT; NO FURTHER REPORTS REGARDING THIS EVENT WILL BE SUBMITTED. TWO USED WIRE GUIDE WERE RETURNED AND EVALUATED. ONE WIRE GUIDE WAS A HIWIRE STANDARD-BODY WIRE GUIDE (HW-035150) AND ONE WAS A HIWIRE STANDARD-BODY WIRE GUIDE WITH ANGLED TIP (HWA-035150). THE RETURNED WIRE GUIDES WERE INSPECTED BY THE SUPPLIER AND AT 10X MAGNIFICATION OVER THE ENTIRE LENGTH WHILE ROTATING THE WIRE UNDER THE SCOPE. NEITHER SPECIMEN PRESENTED ANY VISUAL OR TACTILE INDICATION OF COATING DAMAGE OR POLYMER JACKET REMOVAL OR DAMAGE. BOTH OF THE WIRE GUIDES ALSO HAD BENDS THAT WERE NOT REPORTED AND LIKELY OCCURRED IN RETURN SHIPPING. THE COOK REPRESENTATIVE FOR THE CUSTOMER WHO RETURNED THE DEVICE CONFIRMED THEY BELIEVED THEY WERE THE CORRECT DEVICES TO BE RETURNED, ALTHOUGH THEY WERE WERE UNCERTAIN WHICH OF THE TWO DEVICES WERE THE COMPLAINT DEVICE. HENCE THEY HAD RETURNED BOTH. THE EVIDENCE FROM THE COMPLAINT FILE, SUPPLIER REVIEW OF MANUFACTURING DOCUMENTS AND COMPLAINT DEVICE INDICATES THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION AS WELL AS OTHER ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE. BASED ON THE INFORMATION PROVIDED, THE MOST PROBABLE CAUSE OF THIS EVENT IS RELATED TO CONCOMITANT DEVICE USE, AS THE USER REPORTED A SEPARATED PIECE WITHIN THE PATIENT, HOWEVER, THE RETURNED COOK DEVICE HAD NO VISIBLE SIGNS OF DAMAGE. IT IS LIKELY THAT THE FOREIGN MATTER WAS FROM ANOTHER DEVICE USED DURING THE PROCEDURE (IE NEPHROSCOPE, BALLOON DILATORS, STENTS, OTHER GUIDEWIRES USED DURING THE PROCEDURE). THE COMPLAINT WAS NOT CONFIRMED AS THE AVAILABLE EVIDENCE INDICATES THE RETURNED COMPLAINT DEVICES DID NOT CONTRIBUTE TO THE COMPLAINT.

Additional Manufacturer Narrative · 0

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.

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION: B5, D9, G4 CORRECTION: D1, D2, D4- CATALOG#, D10, H3, 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.