GALAXY G3 XSFT HEL 2MM X 8CM

Report

Report Number: 3008114965-2020-00522
Event Type: Malfunction
Date Received: December 1, 2020
Date of Event: November 13, 2020
Report Date: November 13, 2020
Manufacturer: MEDOS INTERNATIONAL SARL
Product Code: KRD
UDI-DI: 10886704077763
PMA / PMN Number: K150319
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 12/21/2020. [ADDITIONAL EVENT INFORMATION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / K10418) WAS USED. THE COIL WAS INSERTED INTO THE CONCOMITANT CARNELIAN® MARVEL® MICROCATHETER (TOKAI MEDICAL PRODUCTS), BUT THERE WAS RESISTANCE BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER. THE PHYSICIAN REMOVED THE COIL AND NOTICED THAT THE COIL HAD UNRAVELED. IT WAS REPLACED WITH ANOTHER 2MM X 8CM GALAXY G3 XSFT HELICAL COIL FROM THE SAME LOT (K10418) AND IT WAS USED WITHOUT ANY ISSUE. THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. IT WAS REPORTED THAT THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN DUE TO INFECTIOUS DISEASE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THERE WAS NO BLOOD FLOW RESTRICTION OR REDUCTION AS A RESULT OF THE REPORTED EVENT. THE REPORTED EVENT ALSO DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. E.1: THE INITIAL REPORTER PHONE: (B)(6) . THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

MANUFACTURERS REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. (B)(4). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / K10418) WAS USED. THE COIL WAS INSERTED INTO THE CONCOMITANT CARNELIAN¿ MARVEL¿ MICROCATHETER (TOKAI MEDICAL PRODUCTS), BUT THERE WAS RESISTANCE BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER. THE PHYSICIAN REMOVED THE COIL AND NOTICED THAT THE COIL HAD UNRAVELED. IT WAS REPLACED WITH ANOTHER 2MM X 8CM GALAXY G3 XSFT HELICAL COIL FROM THE SAME LOT (K10418) AND IT WAS USED WITHOUT ANY ISSUE. THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. IT WAS REPORTED THAT THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN DUE TO INFECTIOUS DISEASE. BASED ON COMPLAINT INFORMATION, THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (K10418) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. COIL UNRAVELING / STRETCHING IS A KNOWN POTENTIAL ISSUE ASSOCIATED WITH THE USE OF THIS DEVICE. THE INSTRUCTION FOR USE (IFU) PROVIDES PROPER HANDLING INSTRUCTIONS FOR THE DEVICE TO PREVENT SUCH ISSUE FROM OCCURRING. THE EMBOLIC COIL CAN BECOME UNRAVELED OR STRETCHED DURING ATTEMPTS TO WITHDRAWAL IT AGAINST RESISTANCE. IT CAN ALSO UNRAVEL OR STRETCH IF THERE WAS EXCESSIVE FORCE APPLIED / EXERTED ON IT DURING PROCEDURAL HANDLING. INTERACTION WITH CONCOMITANT DEVICE(S) MAY ALSO RESULT IN THE COIL BECOMING UNRAVELED / STRETCHED. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE EMBOLIC COIL AND THE CONCOMITANT MICROCATHETER AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem · 1

THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 2MM X 8CM GALAXY G3 XSFT HELICAL COIL (GLX120208 / K10418) WAS USED. THE COIL WAS INSERTED INTO THE CONCOMITANT CARNELIAN¿ MARVEL¿ MICROCATHETER (TOKAI MEDICAL PRODUCTS), BUT THERE WAS RESISTANCE BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER. THE PHYSICIAN REMOVED THE COIL AND NOTICED THAT THE COIL HAD UNRAVELED. IT WAS REPLACED WITH ANOTHER 2MM X 8CM GALAXY G3 XSFT HELICAL COIL FROM THE SAME LOT (K10418) AND IT WAS USED WITHOUT ANY ISSUE. THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. IT WAS REPORTED THAT THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN DUE TO INFECTIOUS DISEASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1390359	GALAXY G3 XSFT HEL 2MM X 8CM	NEUROVASCULAR EMBOLIZATION DEVICE	KRD	MEDOS INTERNATIONAL SARL	GLX120208	K10418	10886704077763

Patients

Seq	Age	Sex	Outcome	Treatment
1				CARNELIAN® MARVEL® MICROCATHETER (TOKAI)