ENCOR BIOPSY PROBE
Report
- Report Number
- 2020394-2019-02015
- Event Type
- Malfunction
- Date Received
- July 30, 2019
- Date of Event
- July 3, 2019
- Report Date
- December 23, 2019
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- KNW
- UDI-DI
- 00801741086281
- PMA / PMN Number
- K051158
- Removal / Correction Number
- Z-2211-2019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
A CUSTOMER NOTIFICATION WAS ISSUED FOR THE ENCOR BREAST BIOPSY PROBE FOR SPECIFIC PRODUCT CODE/LOT NUMBER COMBINATIONS. THE AFFECTED PRODUCT CODE/LOT NUMBER COMBINATIONS MAY BE AT RISK OF EXPERIENCING A LEAK BETWEEN THE PROBE AND THE TISSUE COLLECTION CHAMBER, WHICH COULD RESULT IN MINIMAL SUCTION, LEAKAGE, MINIMAL OR NO TISSUE SAMPLE OBTAINED, OR AN EGRESS OF FLUIDS FROM THE DEVICE. A ROOT CAUSE INVESTIGATION AND FIELD ACTION DETERMINATION WAS CONDUCTED AS A RESULT OF AN INCREASE IN COMPLAINTS FOR LEAKS, SUCTION ISSUES, AND FAILURE TO OBTAIN SAMPLES. THE INVESTIGATION INCLUDED AN EXTENSIVE MANUFACTURING REVIEW, RISK DOCUMENTATION REVIEW FOR THE THREE REPORTED MALFUNCTIONS, AND EVALUATIONS PERFORMED ON THE RETURNED DEVICES. THE INVESTIGATION IDENTIFIED THAT ONE OF THE FEATURES ON THE TRAP CHAMBER WAS UNDER SPECIFIED AND DURING THE IMPLEMENTATION OF A NEW TRAP CHAMBER (DC2448) MOLD, ONE OF THE DIMENSIONS CHANGED AND WENT UNDETECTED, CREATING A DIFFERENCE BETWEEN THE AMOUNT OF SPACE THAT THE SEAL HAS BETWEEN THE TRAP CHAMBER AND THE FRONT SEAL CAP. THIS GAP BETWEEN THE TRAP CHAMBER AND FRONT SEAL CAP RESULTED IN CONDITIONS THAT LED TO A HIGHER LIKELIHOOD OF LEAKS, SUCTION ISSUES, AND FAILURE TO OBTAIN SAMPLES. ALL REPORTED COMPLAINTS FROM THE AFFECTED PRODUCT CODE/LOT NUMBER COMBINATIONS THAT ARE POSSIBLY RELATED TO THE GAP BETWEEN THE TRAP CHAMBER AND FRONT SEAL CAP HAVE BEEN CLASSIFIED AS LEAK, SUCTION ISSUES), OR FAILURE TO OBTAIN SAMPLES. THIS REPORTED COMPLAINT IS FROM AN AFFECTED LOT NUMBER THAT WAS REPORTED FOR ONE OF THESE TRAP CHAMBER ISSUES.
IT WAS REPORTED THAT DURING A BREAST BIOPSY WITH ULTRASOUND GUIDANCE, THE PROBE ALLEGEDLY FAILED TO CALIBRATE AND THE SYSTEM REPORTED " INSUFFICIENT VACUUM". IT WAS FURTHER ALLEGED THAT AIR LEAKAGE COULD BE HEARD FROM THE SEAL BETWEEN THE PROBE BODY AND THE SAMPLE TRAY. THERE WAS NO REPORTED PATIENT INJURY.
THIS EVENT IS BEING REPORTED AS A REPORTABLE MALFUNCTION FOR THE SPECIAL CAUSE RELATED TO THESE PRODUCT CATALOG/LOT NUMBER COMBINATIONS WHICH IS THE SUBJECT OF REPORT OF CORRECTIONS AND REMOVAL LETTER (806 NOTIFICATION) ON MAY 2, 2019. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (B)(4), EXPIRY DATE-07/2020.
IT WAS REPORTED THAT DURING A BREAST BIOPSY WITH ULTRASOUND GUIDANCE, THE PROBE ALLEGEDLY FAILED TO CALIBRATE AND THE SYSTEM REPORTED " INSUFFICIENT VACUUM". IT WAS FURTHER ALLEGED THAT AIR LEAKAGE COULD BE HEARD FROM THE SEAL BETWEEN THE PROBE BODY AND THE SAMPLE TRAY. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636861 | ENCOR BIOPSY PROBE | BIOPSY INSTRUMENT | KNW | BARD PERIPHERAL VASCULAR, INC. | ECP017G | VTCU0342 | 00801741086281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |