VASCULAR SOLUTIONS, LLC ONCONTROL; ONCONTROL® BONE LESION BIOPSY SYSTEM TRAY 11GA 10CM / 13GA 14CM (6/BX
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Model Number 9464-VC-006 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2021 |
Event Type
Injury
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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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Event Description
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As reported: the user approached the bone tumor tissue with the on control access needle.However, the needle rotation was slow on ct, and the puncture did not proceed.Then, the needle began to heat up so that the user stopped using it.The user changed to a manual biopsy and continued the approach, but as a result, the procedure itself was completed.Later, when the user verified the ct image, it was found that the tip of the needle was dull.Therefore, the user was worried that the tip of the needle might have come off during the operation and that there were no remnants in the patient.Additional information received 20dec2021: by reconfirming ct fluoroscopy image by the user, it was found that no fragment was left in the patient, and the needle tip was not worn.The osteosclerotic lesion was too hard for the access needle to reach near the lesion.From the image findings, it was found that the rotation of the driver was not sufficiently transmitted.
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Manufacturer Narrative
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One-unit of trapliner was returned for evaluation.Blood particulates were noted on the unit.The balloon was fatigued with blood particulates within the balloon.No damages noted on the rx lumen.Weld joint separation was confirmed.Small layer of pebax at the proximal part of the half was damaged.The device history records were reviewed.There are no nonconformances related to this lot therefore supporting the device met material, assembly, and performance specifications.Case details were reviewed.A patient underwent a pci procedure.A trapliner was used.Upon inflation of the balloon, blood was observed to flow back into the inflation syringe.Damages are likely to have occurred during use in the procedure.Per ifu, states the following precaution: exercise care in handling the catheter during a procedure to reduce the possibility of accidental breakage or kinking.Do not apply torque to the catheter during delivery, as catheter damage may result.Additional information was requested from the account.A response was received.Vessel was lad.Trapliner was prepped without any issues.Trapliner broke at the flex point and was removed.It is likely that the catheter weld joint was damaged during use leading to partial damage at the hypo tube causing blood to flow back in the balloon and back into the syringe.The complete separation could have then occurred when removed from the body.Account stated that the trapliner was intact when removed in its entirety and then separated.Procedure was completed with another trapping balloon unit.No patient harm noted, and procedure outcome was successful.Based on the information, the most likely root cause of the issue is operation context and/or unintended use error.
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Manufacturer Narrative
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Correction made that the device is oncontrol and not trapliner.This is an updated report for fu2-2134812-2022-00006 oncontrol: there was no product returned for this complaint.No returned product evaluation could be completed.A manufacturing record review was completed by the supplier of oncontrol needles, and no related nonconformances were found.Case details were reviewed.The event description states user approached a bone tumor tissue with the access needle.The needle rotation was slow however needle began to heat up.It is unknown if there were any shaft damages with the cannula.It is unknown if excessive forced was applied per ifu, states that following instructions for use: do not apply excessive force to driver/ needle set additional information was requested.A response was received.Sample was discarded.No fragment left in the patient.The osteosclerotic lesion was too hard for access needle to reach.The rotation of the driver was not sufficiently transmitted.It is likely due to the density of the bone, torque applied by the driver not being transmitted could lead to the heating of the needle if is not moving linearly (i.E.In depth) towards the lesion.It is unknown if density of the bone alone was the factor contributing to or if there was a connection failure between driver-connector and needle.The bone location was lung adenocarcinoma with multiple bone metastases.The rotation was smooth until the l1 surface but when approaching bone tumor, only two rotations per 3 seconds was noted.User stated that during ct image, the tip of needle was observed to be dull.However, no fragments were left and confirmed the tip to be not worn.No images were shared by the account.Case was completed using a manual approach.Based on the information, the most likely root cause of the issue is undeterminable.
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