MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONF INTRO NDLE, BEV, 11G 4"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	283902411
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348); No Code Available (3191)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Per reporter: patient came in to get a vertebroplasty in the angiography suites.This is a routine procedure that the neuroradiologist does.They had put cement in on one side and was ready to do the same on the other side of the vertebral body.However as they were about to take out the beveled tip introducer to replace it with the cement introducer- they could not take it out.After attempts, the handle came off, leaving the needle in the vertebral body.We tried various ways of taking the needle out ¿ including slaphammer, different forceps (kelly, kochers), different rod holders but in the end they had to transfer the patient up to main theatres where a neurospinal consultant opened up the patient.He successfully retrieved the needle by drilling around it and then pulling it out.Both doctors made mention that the patient is highly sclerotic making the bone very hard.

• Brand Name: CONF INTRO NDLE, BEV, 11G 4"
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7986235
• Report Number: 1526439-2018-50998
• Device Sequence Number: 16188668
• Product Code: GAA
• UDI-Device Identifier: 10705034209401
• UDI-Public: (01)10705034209401
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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: 283902411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other