MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-03 for ULTRACOR TWIRL MARKER UCTW17 manufactured by Bard Peripheral Vascular, Inc..
[175112833]
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. (expiry date: 11/2021).
Patient Sequence No: 1, Text Type: N, H10
[175112854]
It was reported that during an ultrasound-guided breast tissue marker placement procedure into hard tissue, the device allegedly was found to be potentially incompatible with the patient. It was further reported that upon test results two weeks post procedure, it was discovered the patient was allegedly allergic to a component of the device. A coaxial was used during the procedure and the procedure was completed by using the same marker. The patient was reportedly stable and will have the marker surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2019-05898 |
| MDR Report Key | 9545998 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-06-05 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2019-01-17 |
| Date Added to Maude | 2020-01-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACOR TWIRL MARKER |
| Generic Name | BREAST TISSUE MARKER |
| Product Code | NEU |
| Date Received | 2020-01-03 |
| Model Number | UCTW17 |
| Catalog Number | UCTW17 |
| Lot Number | HUCY2257 |
| 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 | 1. Required No Informationntervention | 2020-01-03 |