MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for DEVICE, PERCUTANEOUS, BIOPSY VPB11 manufactured by Medtronic Mexico S. De R.l De C.v..
[124528180]
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[124528181]
It was reported that bone marrow biopsy was being performed on a patient with hard bone. Intra-op, plastic hub of the biopsy device came off. When the biopsy device was seated to take the specimen, it stuck in the patient. When trying to remove the device, the plastic top of the device began to spin around the biopsy shaft and the plastic top came off; leaving the shaft stuck in the patient. Finally, the shaft was removed with the help of vice grips and the procedure was completed. No fragment of the broken product remained inside the patient. No patient complications were reported due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612164-2018-02815 |
| MDR Report Key | 7977964 |
| Date Received | 2018-10-18 |
| Date of Report | 2018-10-18 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-10-18 |
| 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 | STACIE ZIEMBA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC MEXICO S. DE R.L DE C.V. |
| Manufacturer Street | AVENIDA PASEO CUCAPAH # 10510 PARQUE INDUSTRIAL EI LAGO |
| Manufacturer City | TIJUANA,BC |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEVICE, PERCUTANEOUS, BIOPSY |
| Generic Name | DEVICE, PERCUTANEOUS, BIOPSY |
| Product Code | MJG |
| Date Received | 2018-10-18 |
| Model Number | NA |
| Catalog Number | VPB11 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MEXICO S. DE R.L DE C.V. |
| Manufacturer Address | AVENIDA PASEO CUCAPAH # 10510 PARQUE INDUSTRIAL EI LAGO TIJUANA,BC MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-18 |