MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for ENCOR BIOPSY PROBE ECP017G manufactured by Bard Peripheral Vascular, Inc..
[185757969]
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 ((b)(4)) 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. (expiry date 10/2020), (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185757970]
It was reported that during an ultrasound guided breast biopsy through calcified tissue, device allegedly had a suction issue. The procedure was completed using another device. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2020-02136 |
| MDR Report Key | 9889935 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | INFUS MEDICAL (THAILAND) |
| Manufacturer Street | 706 MOO 4 BANGPOO IND ESTATE |
| Manufacturer City | SAMUTPRAKARN PROVINCE 10280 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 10280 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2211-2019 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENCOR BIOPSY PROBE |
| Generic Name | BIOPSY INSTRUMENT |
| Product Code | KNW |
| Date Received | 2020-03-27 |
| Model Number | ECP017G |
| Catalog Number | ECP017G |
| Lot Number | VTCX0488 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |