MAUDE Adverse Event Report: VASCULAR SOLUTIONS LLC ONCONTROL; BIOPSY NEEDLE KIT

Catalog Number	9458-VC-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: dr.Performing bmb and biopsy needle broke off in patient when in use.Needle still stuck in iliac crest.Additional information: physician was using a bmb kit on a hard, sclerotic bone lesion biopsy.Physician did not expect the patient to have hard bones.He was not able to advance with needle , so he tried to redirected cannula with driver , excessive force was used.He believes the needle was stuck in the bone and snapped the cannula when he was trying to redirect.I mentioned to physician that the bml tray would have probably been a better cannula to cut through the hard bone, he agreed.2cm of cannula tip was imbedded in patients' bone and were unable to retrieve.They decided to leave the piece in the body since it would not be harmful to patient.Patient is fine and physician does not feel it was device fault.Went over trays with physician to show the difference of the cannula tips in the bmb kits and bml.For hard bone, bml is the appropriate kit to use to help cut better.Physician will use bml on the hard bone cases.
Additional Manufacturer Narrative
(b)(4).There was no product returned for this complaint.No returned product evaluation could be completed.Pictures were sent by the customer.A piece of the cannula was observed to be missing.Viant is the supplier for oncontrol needles.A dhr review was completed for lot 70850302.No issues or non-conformances were noted.All processes were followed.Case details were reviewed.Customer stated "dr.Performing bmb and biopsy needle broke off in patient when in use.Needle still stuck in iliac crest." no unit was returned to vsi/teleflex for evaluation.A picture was shared by the customer confirming cannula shaft separation.Additional information was requested.A response was received.The bone was sclerotic.Physician was using a bmb kit on a hard bone lesion biopsy.Per ifu 107368 rev a states the following the arrow oncontrol bone marrow aspiration system is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients.The arrow oncontrol bone marrow biopsy system is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients.Needle was stuck in the bone and snapped the cannula when he was trying to redirect.Bmb cannula broke inside the patient.The piece was left inside the bone and unable to be retrieved.Per the customer, approximately 2 cm of the shaft was missing.Excessive force was applied with the driver.Per step 5 of the ifu , locate insertion site with needle set on the periosteum.Note depth marking.Squeeze trigger to penetrate cortex to medullary space.Do not apply excessive force to driver/needle set.Another bmb was not performed.A manufacturing record review was completed by viant and no related nonconformances were found.Based on the information, the most likely root cause of the issue is user error.
Event or Problem Description
It was reported that: dr.Performing bmb and biopsy needle broke off in patient when in use.Needle still stuck in iliac crest.Additional information: physician was using a bmb kit on a hard, sclerotic bone lesion biopsy.Physician did not expect the patient to have hard bones.He was not able to advance with needle , so he tried to redirected cannula with driver , excessive force was used.He believes the needle was stuck in the bone and snapped the cannula when he was trying to redirect.I mentioned to physician that the bml tray would have probably been a better cannula to cut through the hard bone, he agreed.2cm of cannula tip was imbedded in patients' bone and were unable to retrieve.They decided to leave the piece in the body since it would not be harmful to patient.Patient is fine and physician does not feel it was device fault.Went over trays with physician to show the difference of the cannula tips in the bmb kits and bml.For hard bone, bml is the appropriate kit to use to help cut better.Physician will use bml on the hard bone cases.

• Brand Name: ONCONTROL
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): VASCULAR SOLUTIONS LLC; minneapolis MN
• Manufacturer (Section G): VASCULAR SOLUTIONS LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17622042
• Report Number: 2134812-2023-00041
• Device Sequence Number: 7302014
• Product Code: FCG
• UDI-Device Identifier: 10841156108502
• UDI-Public: 10841156108502
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9458-VC-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Age: 74 YR
• Patient Sex: Female