MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-19 for TEMNO NEEDLE BIOPSY ACT2211 manufactured by Merit Medical Systems Inc..
[184662103]
The account alleges that during a biopsy procedure, the tip of a biopsy needle detached within the patient's tumor. The initial two previous passes of the biopsy needle were successful. On the third pass, the clinician noted that it was much stiffer and after firing the tip detached within the tumor. An additional biopsy device was utilized to obtain several more specimens from the patient without incidence. The patient was discharged to home with the detached tip embedded within the patient's the tumor. No complications have been experienced by the patient. It was noted that the detached tip will be retrieved when the tumor is surgically removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721504-2020-00017 |
| MDR Report Key | 9857535 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-18 |
| Date Added to Maude | 2020-03-19 |
| 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 | MR. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT |
| Manufacturer Country | US |
| Manufacturer Phone | 2054551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN, UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMNO NEEDLE BIOPSY |
| Generic Name | BIOPSY NEEDLE |
| Product Code | FCG |
| Date Received | 2020-03-19 |
| Catalog Number | ACT2211 |
| Lot Number | 0001261270 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS INC. |
| Manufacturer Address | 1600 MERIT PARKWAY SOUTH JORDAN, US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |