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Model Number 9407-VC-006 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hematoma (1884)
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Event Date 03/17/2022 |
Event Type
Injury
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Event Description
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As reported: this is a 70 year old male with a history of nhl (2008) and recent diagnosis of myeloma ((b)(6) 2022) from c3 vertebral body.A bone marrow biopsy was performed on 3/17/22 from the right side using a power-driven needle (oncontrol system) without difficulty.He was discharged home following the procedure.He noted shoulder pain following the procedure and was seen at an urgent care center on (b)(6) 2022, without acute process.On (b)(6) 2022 he was sent to the ec, by his oncologist due to concerns for low hemoglobin (6.3g/dl) requiring transfusion.A ct scan was performed on (b)(6) 2022, which identified a heterogeneous mildly hyperdense mass-like area in the right gluteal musculature, predominantly in the gluteus medius, which was also seen on the ct portion of the pet scan on (b)(6) 2022 (i could not find this described in the pet scan), without reported increased uptake on that study.It has increased since that exam and favors an enlarging intramuscular hematoma.A cta of the lower extremity ((b)(6) 2022) identified a moderate to large sized intramuscular hematoma involving the right gluteal musculature and right adductor musculature extending to the right knee without evidence of active extravasation.Evaluated by surgery team with no need for surgical intervention.During hospitalization ((b)(6) 2022) also noted to have confusion and evaluated by neurology.Mri of the brain ((b)(6) 2022) showed a small acute to subacute infarct in the left frontal lobe.However, neurology felt confusion was more likely related to anemia, delirium and steroids rather than acute stroke.Hematoma improved and hemoglobin stabilized.He progressed well and was transferred to inpatient rehab ((b)(6) 2022).Discharged home on (b)(6) 2022.
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Manufacturer Narrative
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An investigation has been opened and a follow-up report will be submitted after investigation.
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Manufacturer Narrative
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There was no product returned for this complaint.No returned product evaluation could be completed.There was no lot number provided for this complaint.Therefore, no record review could be completed by the supplier for the on control needles.Case details were reviewed.A patient underwent a bone marrow biopsy on (b)(6) 2022 on the right side.Patient was sent to urgent care for shoulder pain on (b)(6) 2022.On (b)(6) 2022, he was sent to the ec, by his oncologist due to concerns for low hemoglobin (6.3g/dl) requiring transfusion.A ct scan was performed on (b)(6) 2022, which identified a heterogeneous mildly hyperdense mass-like area in the right gluteal musculature, predominantly in the gluteus medius, which was also seen on the ct portion of the pet scan of (b)(6) 2022.A cta of the lower extremity ((b)(6) 2022) identified a moderate to large sized intramuscular hematoma involving the right gluteal musculature and right adductor musculature extending to the right knee without evidence of active extravasation.No picture or angiograms of the issue was shared.No product was returned for evaluation.Ifu states the following: loss of sensitivity, pain and hematoma are potential side effects from using the on control bone marrow aspiration and bone marrow biopsy system.Additional information was requested.A response was received.Two passes were made to collect the sample.Sample was adequate for diagnosis.Other questions related to lot number and ct images were not shared.It is unknown and unclear if vessel damages could have occurred during biopsy procedure or if any other anatomical factors led to the issue.It is unknown if the needle was set into the bone too shallow or too far causing damages to vessel or hitting undesired targets.Based on the information, the most likely root cause of the issue is undeterminable.
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Search Alerts/Recalls
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