N
Patient 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.
MAUDE MDR 6427462
- MDR report key
- 6427462
- Report number
- 1820334-2017-00542
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-02-16
- Date received
- 2017-03-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. LARRY POOL
- Address
- 750 DANIELS WAY BLOOMINGTON IN 47404 US
- Phone
- 812-812-8123
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-03-23 | 0 | 1. O; 2. R |
Event Narratives#
D
Patient 1
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT A BREAST EXCISION ON (B)(6) 2016 WITH PLACEMENT OF A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2017 WITH A COMPLAINT THAT A SECTION OF THE WIRE CAME OUT OF HER BREAST. THE SURGICAL SITE WAS EXAMINED AND REPORTEDLY "EVERYTHING IS FINE AND NO INFECTION" WAS FOUND. THE PATIENT GAVE THE EXTERNALIZED SECTION OF THE NEEDLE TO THE PHYSICIAN. THE CIRCUMSTANCES AND HANDLING OF THE DEVICE FOR TWO MONTHS POST BREAST EXCISION ARE NOT KNOWN. NO FURTHER INFORMATION WAS PROVIDED.
N
Patient 1
INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, TRENDS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE CUSTOMER RETURNED ONLY THE HOOKWIRE COMPONENT OF A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE; THE NEEDLE PORTION OF THE DEVICE WAS NOT RETURNED. THE HOOKWIRE WAS RETURNED IN A USED CONDITION. INITIAL VISUAL INSPECTION CONFIRMED THAT SOME BIOMATTER WAS PRESENT ON THE DEVICE. A PORTION OF THE WIRE WAS BROKEN OFF AND WAS NOT RETURNED WITH THE DEVICE. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF 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. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE; SPECIFIC ITEMS ARE ADDRESSED SUCH AS: "PRECAUTIONS: THE PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. STANDARD TECHNIQUES FOR LOCALIZATION OF BREAST LESIONS SHOULD BE EMPLOYED. FOLLOWING PLACEMENT OF THE HOOKWIRE, THE PORTION PROTRUDING OUTSIDE OF THE BREAST SHOULD BE BENT AND TAPED TO THE SKIN TO PREVENT INADVERTENT MOVEMENT. FINAL HOOKWIRE POSITION SHOULD BE CONFIRMED BY AN APPROPRIATE IMAGING MODALITY. INSTRUCTIONS FOR USE: 1. INTRODUCE THE NEEDLE INTO THE LESION. 2. CHECK THE POSITION OF THE NEEDLE. 3. ADVANCE AND RELEASE THE HOOKWIRE. 4. REMOVE THE NEEDLE. 5. BEND THE HOOKWIRE PROTRUDING FROM THE BREAST AND TAPE FLAT TO THE SKIN. 6. VERIFY FINAL HOOKWIRE POSITION." BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PARTIAL PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.