MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2016-11-18 for OSTEO-SITE BONE BIOPSY NEEDLE N/A DBBN-13-15.0 manufactured by Cook Inc.
[60312108]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[60312109]
Zhi li, md, et al: cement embolus trapped in the inferior vena cava filter during percutaneous vertebroplasty korean j radiol 2013;14(3):451-454. A (b)(6) female patient, diagnosed with adenocarcinoma of the lung, underwent percutaneous vertebroplasty (pvp) at the l4 vertebral body due to painful spinal metastases. Because of deep venous thrombosis of the left femoral and iliac veins, an inferior vena cava filter had been placed before vertebroplasty. Bone cement migrated into the venous bloodstream and then was being trapped within the previously placed filter. The patient had a history of lung cancer was referred for low back pain, left lower-limb swelling, cough and expectoration. Her low back pain was getting aggravated and the pain could not be controlled by analgesics. Computed tomography (ct) scan of spine revealed osteolytic metastatic lesion in the body of l4 without paravertebral space involvement. Ultrasound examination revealed free thrombus in the left iliac-femoral vein. To prevent pulmonary embolism (pe), a permanent ivc filter was inserted in the ivc, before pvp was scheduled. The pvp procedure was performed under local anesthesia,by using a unilateral approach with a 13-gauge needle and it was guided by a digital subtraction angiography (dsa) fluoroscopy. When the needle tip reached the one third of the anterior l4 vertebral body, intraosseous venography was performed,which showed a rapid venous filling :contrast material exited though the anterior external vertebral venous plexuses and emptied into the ivc. We repositioned the needle tip to avoid extravasation. However, venography findings were the same as before. The cement was prepared by mixing a 2 g of sterile barium sulfate powder (made by our hospital) for opacification, and was injected with a simple syringe during a paste-like viscosity. When the l4 vertebral body was nearly filled, fluoroscopy showed cement leaking into the ivc, and migrating to the filter. The injection of the cement was interrupted immediately; a total of 5 ml bone cement had been injected. The patient was hemodynamically stable, and no cardiopulmonary function disturbances were noted. The patient was discharged 10 days after pvp, and was followed-up at the outpatient department. There were no complications that occurred, which related to the filter, within the 8 months of follow-up. After the procedure of pvp, the low back pain of the patient was obviously released. No evidence of pe or ivc perforation presented. The left lower limb swelling of the patient was recovered 1 week later.
Patient Sequence No: 1, Text Type: D, B5
[79155277]
Investigation - evaluation: a review of the complaint history, drawings, documentation, instructions for use (ifu) and quality control was conducted during the investigation. The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The lot number of the device is not known; accordingly a review of the device history record could not be conducted. No statement is made about difficulty positioning the needle or failure of the needle in its delivery role. The bone cement used was not a cook product. Bone cement leakage from the vertebral body is a known complication of percutaneous vertebroplasty. No device complaint (failure mode) is articulated in the journal article and there is no evidence to suggest the needle failed to perform as designed during the procedure or was not manufactured to specifications. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2016-01394 |
| MDR Report Key | 6112465 |
| Report Source | LITERATURE |
| Date Received | 2016-11-18 |
| Date of Report | 2017-06-01 |
| Date of Event | 2012-02-16 |
| Date Mfgr Received | 2017-05-17 |
| Date Added to Maude | 2016-11-18 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEO-SITE BONE BIOPSY NEEDLE |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2016-11-18 |
| Model Number | N/A |
| Catalog Number | DBBN-13-15.0 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-18 |