QUICK-CORE COAXIAL BIOPSY NEEDLE SET

Report

Report Number: 1820334-2017-02170
Event Type: Injury
Date Received: July 27, 2017
Date of Event: July 12, 2017
Report Date: January 10, 2018
Manufacturer: COOK INC
Product Code: KNW
UDI-DI: 00827002087903
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PMA/510(K) #: K973565. INVESTIGATION - EVALUATION: A REVIEW OF DIMENSIONAL VERIFICATION, INSPECTION OF UNUSED PRODUCT, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE, SPECIFICATIONS, VISUAL INSPECTION, AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE INVOLVED IN THIS COMPLAINT WAS DISPOSED OF AND SO WAS NOT RETURNED; HOWEVER, THE CUSTOMER DID RETURN 49 ADDITIONAL UNOPENED DEVICES. FOUR OF THESE DEVICES CONTAINED BIOPSY NEEDLES FROM THE SAME SUPPLIER LOT AS THE DEVICE INVOLVED IN THIS COMPLAINT; THESE 4 DEVICES WERE EXAMINED THROUGH A DEVICE FAILURE ANALYSIS. THE 4 DEVICES WERE ALL FOUND TO BE MANUFACTURED WITHIN SPECIFICATION. A DOCUMENT-BASED INVESTIGATION EVALUATION SHOWED NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE PROVIDED INFORMATION, INSPECTION OF RETURNED PRODUCT, AND THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED OR REPORTED AT THIS TIME. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT.

Additional Manufacturer Narrative · 1

(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

Additional Manufacturer Narrative · 1

(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A RENAL BIOPSY USING A QUICK-CORE COAXIAL BIOPSY NEEDLE SET. TWO QUICK-CORE COAXIAL BIOPSY NEEDLE SETS WERE USED IN AN ATTEMPT TO GAIN A SUCCESSFUL BIOPSY. BOTH ATTEMPTS WERE NOT SUCCESSFUL; THE CUSTOMER OBTAINED A COMPETITOR PRODUCT AND COMPLETED THE PROCEDURE. THE CUSTOMER REPORTS "THE QUICK CORE COAXIAL BIOPSY NEEDLE CAUSED A HEMATOMA IN A PATIENT DURING OR AFTER A BIOPSY IN THE KIDNEY." THE CUSTOMER ADVISED THAT AN ADDITIONAL LAB WAS NEEDED DUE TO THE HEMATOMA. NO FURTHER INFORMATION WAS PROVIDED; ADDITIONAL PATIENT AND EVENT DETAILS WERE REQUESTED. THIS IS ONE OF TWO REPORTS BEING SUBMITTED. REFERENCE MDR NUMBERS 1820334-2017-02170 AND 1820334-2017-02172 FOR THE TWO DEVICES. THE SAME PATIENT IS INVOLVED IN EACH REPORT. ADDITIONAL INFORMATION WAS LATER REPORTED BY THE CUSTOMER IN A RESPONSE TO A REQUEST FOR ADDITIONAL INFORMATION. THE HEMATOMA WAS IDENTIFIED AFTER THE BIOPSY, BUT DURING THE POST PROCEDURE COMPUTED TOMOGRAPHY SCAN THAT IMMEDIATELY FOLLOWED THE REMOVAL OF THE NEEDLE. THE LABS THAT WERE NECESSITATED DUE TO THE ISSUE WERE HEMOGLOBIN AND HEMATOCRIT. THE PATIENT WAS NOT ON AN ANTICOAGULANT PRIOR TO OR AFTER THE BIOPSY, AND THE PATIENT STATUS IS REPORTEDLY RESOLVED CURRENTLY. FURTHER REVIEW OF THE RECORD IDENTIFIED THAT CLINICAL ACTION FOR THE HEMATOMA ALSO INCLUDED OBSERVATION. RATIONALE FOR 2 MEDWATCH REPORTS: MDR NUMBER 1820334-2017-02170 ADDRESSES THE HEMATOMA ON THE SECOND DEVICE AND MDR NUMBER 1820334-2017-02172 ADDRESSES THE UNCONFIRMED HEMATOMA THAT WAS REPORTED ON THE FIRST DEVICE. ADDITIONAL INFORMATION RECEIVED CLARIFIED, " THE INABILITY TO OBTAIN A SPECIMEN WITH INITIAL NEEDLE PLACEMENT REQUIRED ADDITIONAL NEEDLE ACCESS, WHICH LED TO HEMATOMA/LABWORK/ ADDITIONAL RECOVERY TIME." THEREFORE, IT IS IDENTIFIED THAT THE HEMATOMA REFERS TO THE SECOND DEVICE (1820334-2017-02170) ONLY.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A RENAL BIOPSY USING A QUICK-CORE COAXIAL BIOPSY NEEDLE SET. TWO QUICK-CORE COAXIAL BIOPSY NEEDLE SETS WERE USED IN AN ATTEMPT TO GAIN A SUCCESSFUL BIOPSY. BOTH ATTEMPTS WERE NOT SUCCESSFUL; THE CUSTOMER OBTAINED A COMPETITOR PRODUCT AND COMPLETED THE PROCEDURE. THE CUSTOMER REPORTS "THE QUICK CORE COAXIAL BIOPSY NEEDLE CAUSED A HEMATOMA IN A PATIENT DURING OR AFTER A BIOPSY IN THE KIDNEY." THE CUSTOMER ADVISED THAT AN ADDITIONAL LAB WAS NEEDED DUE TO THE HEMATOMA. NO FURTHER INFORMATION WAS PROVIDED; ADDITIONAL PATIENT AND EVENT DETAILS WERE REQUESTED. THIS IS ONE OF TWO REPORTS BEING SUBMITTED. REFERENCE MDR NUMBERS 1820334-2017-02172 FOR THE TWO DEVICES. THE SAME PATIENT IS INVOLVED IN EACH REPORT.

Description of Event or Problem · 1

CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A RENAL BIOPSY USING A QUICK-CORE COAXIAL BIOPSY NEEDLE SET. TWO QUICK-CORE COAXIAL BIOPSY NEEDLE SETS WERE USED IN AN ATTEMPT TO GAIN A SUCCESSFUL BIOPSY. BOTH ATTEMPTS WERE NOT SUCCESSFUL; THE CUSTOMER OBTAINED A COMPETITOR PRODUCT AND COMPLETED THE PROCEDURE. THE CUSTOMER REPORTS "THE QUICK CORE COAXIAL BIOPSY NEEDLE CAUSED A HEMATOMA IN A PATIENT DURING OR AFTER A BIOPSY IN THE KIDNEY." THE CUSTOMER ADVISED THAT AN ADDITIONAL LAB WAS NEEDED DUE TO THE HEMATOMA. NO FURTHER INFORMATION WAS PROVIDED; ADDITIONAL PATIENT AND EVENT DETAILS WERE REQUESTED. THIS IS ONE OF TWO REPORTS BEING SUBMITTED. THIS REPORT AND MDR NUMBER 1820334-2017-02172 ARE REFERENCED FOR THE TWO DEVICES. THE SAME PATIENT IS INVOLVED IN EACH REPORT ADDITIONAL INFORMATION WAS LATER REPORTED BY THE CUSTOMER IN A RESPONSE TO A REQUEST FOR ADDITIONAL INFORMATION. THE HEMATOMA WAS IDENTIFIED AFTER THE BIOPSY, BUT DURING THE POST PROCEDURE COMPUTED TOMOGRAPHY SCAN THAT IMMEDIATELY FOLLOWED THE REMOVAL OF THE NEEDLE. THE LABS THAT WERE NECESSITATED DUE TO THE ISSUE WERE HEMOGLOBIN AND HEMATOCRIT. THE PATIENT WAS NOT ON AN ANTICOAGULANT PRIOR TO OR AFTER THE BIOPSY, AND THE PATIENT STATUS IS REPORTEDLY RESOLVED CURRENTLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
526841	QUICK-CORE COAXIAL BIOPSY NEEDLE SET	KNW INSTRUMENT, BIOPSY	KNW	COOK INC	N/A		00827002087903

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention