GALAXY G3 XSFT 3MM X 6CM
Report
- Report Number
- 3008114965-2019-01219
- Event Type
- Malfunction
- Date Received
- October 25, 2019
- Date of Event
- August 7, 2019
- Report Date
- August 8, 2019
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- KRD
- UDI-DI
- 10886704077695
- PMA / PMN Number
- K150319
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT COMPLAINT #: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE VISUAL OBSERVATION OF THE PICTURES RECEIVED AND THE FINDINGS OF THE DEVICE INVESTIGATION. THE EMBOLIC COIL WAS NOTED TO BEING KINKED, MEETING REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. PROCODE: KRD/HCG. INITIAL CONTACT PHONE: (B)(6). MANUFACTURING SITE NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, AN UNKNOWN MICROCATHETER (MC) CAME OUT FROM THE TARGET LESION WHEN A 3MM X 6CM GALAXY G3 XSFT COIL WAS ATTEMPTED TO BE INSERTED. THE PHYSICIAN TRIED TO BE RE-SHEATHED THE COMPLAINT COIL BUT THE SHEATH DID NOT COME OUT FROM THE COIL. THEREFORE, THE COMPLAINT COIL WAS REPLACED WITH ANOTHER PRODUCT AND THE PROCEDURE COMPLETED SAFELY. THE COIL WAS THE SAME SIZE AS INDICATED ON THE LABEL. THE CUSTOMER STATED THAT THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. PRELIMINARY PICTURES WERE RECEIVED. BASED ON THE PICTURES RECEIVED, A VISUAL INSPECTION WAS PERFORMED WHICH IDENTIFIED THE EMBOLIC COIL BEING KINKED. VISUAL INSPECTION WAS PERFORMED BASED ON PICTURES PROVIDED. THE COIL LOOKS BENT, DPU CAME OUT OF THE INTRODUCER AND IS KINKED AT DISTAL AND PROXIMAL END, INTRODUCER LOOKS BENT, AND RE-SHEATHING TOOL LOOKS BROKEN. RH (NOT HEATED) AND HUB LOOK NORMAL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L11395 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ONE NON-STERILE UNIT GALAXY G3 XSFT 3MM X 6CM WAS RECEIVED INSIDE OF A POUCH. THE HUB WAS INSPECTED, AND NO DAMAGES WAS NOTED ON IT. THE DPU WAS INSPECTED AND IT WAS FOUND KINKED AND PARTIALLY PROTRUDED FROM THE INTRODUCER. THE INTRODUCER WAS INSPECTED, AND IT WAS FOUND UNZIPPED. THE RE-SHEATHING TOOL WAS INSPECTED, AND IT WAS FOUND BROKEN IN TWO. ALSO, THE MARKER BAND WAS FOUND AT 41CM FROM HUB, AND IT WAS FOUND WITHIN SPECIFICATION. THE V-NOTCH WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE NOTED ON IT. THE RH WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND IN GOOD CONDITIONS. THE EMBOLIC COIL WAS INSPECTED UNDER MICROSCOPE AND IT WAS FOUND KINKED IN SOME SECTIONS. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE RE-SHEATHING TOOL WAS FOUND BROKEN IN TWO. THE COMPLAINT REPORTED BY THE CUSTOMER ¿COIL INTRODUCER - ZIPPING DIFFICULTY-REZIPPING¿ WAS NOT ABLE TO EVALUATE DUE TO THE RE-SHEATHING TOOL WAS FOUND BROKEN IN TWO. THE COMPLAINT REPORTED BY THE CUSTOMER ¿COIL - POSITIONING DIFFICULTY¿ COULD NOT BE EVALUATED BECAUSE IT IS SPECIFIC TO THE PATIENT AND PROCEDURE AT THE TIME OF OCCURRENCE AND CANNOT BE REPLICATED IN THE LAB. THE KINKED CONDITION NOTED ON THE EMBOLIC COIL AND THE BROKEN CONDITION NOTED ON THE RE-SHEATHING TOOL APPEARS TO HAVE BEEN CAUSED BY EXCESSIVE FORCE AND HANDLING BEING APPLIED TO THE DEVICE HOWEVER NONE OF THOSE CAN BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE MRE SUGGEST THAT THE FAILURE REPORTED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THE GALAXY G3 INSTRUCTIONS FOR USE (IFU) INSTRUCTS THAT UNDER FLUOROSCOPY, DEPLOY THE DETACHABLE COIL BY CAREFULLY PUSHING THE DELIVERY TUBE INTO THE PROXIMAL END OF THE SECOND RHV. CONTINUE PUSHING THE DELIVERY TUBE TO POSITION THE COIL WITHIN THE DESIRED VASCULAR LOCATION. HOLD THE INFUSION CATHETER BODY IN PLACE WHILE THE COIL IS DELIVERED TO PREVENT THE INFUSION CATHETER TIP FROM MOVING FROM ITS INTENDED POSITION. THE IFU CAUTIONS THAT REPOSITIONING THE INFUSION CATHETER WHILE THE COIL IS DEPLOYED CAN LEAD TO DAMAGE AND/OR PREMATURE DETACHMENT OF THE COIL. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE INFORMATION PROVIDED. HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE AND VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUES. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, AN UNKNOWN MICROCATHETER (MC) CAME OUT FROM THE TARGET LESION WHEN A 3MM X 6CM GALAXY G3 XSFT COIL WAS ATTEMPTED TO BE INSERTED. THE PHYSICIAN TRIED TO BE RE-SHEATHED THE COMPLAINT COIL BUT THE SHEATH DID NOT COME OUT FROM THE COIL. THEREFORE, THE COMPLAINT COIL WAS REPLACED WITH ANOTHER PRODUCT AND THE PROCEDURE COMPLETED SAFELY. THE COIL WAS THE SAME SIZE AS INDICATED ON THE LABEL. THE CUSTOMER STATED THAT THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. PRELIMINARY PICTURES WERE RECEIVED. BASED ON THE PICTURES RECEIVED, A VISUAL INSPECTION WAS PERFORMED WHICH IDENTIFIED THE EMBOLIC COIL BEING KINKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1033238 | GALAXY G3 XSFT 3MM X 6CM | NEUROVASCULAR EMBOLIZATION DEVICE | KRD | MEDOS INTERNATIONAL SARL | L11395 | 10886704077695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |