MAUDE Adverse Event Report: NUCLETRON B.V. PROGUIDE SHARP NEEDLE; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number	189616
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.The customer informed that the broken needle was removed from the patient.The patient is not expected to have permanent impairment due to the foreign body.
Event or Problem Description
The customer reported that the proguide needle broke and stayed in the patient after the procedure.
Additional Manufacturer Narrative
New information updated information updated coding new information the investigation was completed by conducting a thorough evaluation of the product and the reported information.The broken needle was identified as a 2 cm fragment of the tip portion of the proguide needle that was used in the original procedure.The scenario that small plastic parts stay behind in the body has been analysed and the severity is estimated as non-serious.The treatment for the patient was completed as intended.The issue is detectable prior to use.The hospital indicates that the patient is not expected to have permanent impairment due to the foreign body.Elekta extensively tested proguide needles and samples from different stock batches but the reported breakages could not be reproduced and elekta are therefore unable to determine a root cause for the problem.No significant differences have been found between different needle lots and material batches.Based on the test data and from a material point of view, it cannot be determined why the needle broke during insertion.The customer's needles have been replaced.The issue could not be reproduced, hence no corrective action has been defined.

• Brand Name: PROGUIDE SHARP NEEDLE
• Common Device Name: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON B.V.; waardgelder 1; veenendaal 3905 TH; NL 3905 TH
• MDR Report Key: 11064509
• Report Number: 9611894-2020-00005
• Device Sequence Number: 19515848
• Product Code: JAQ
• UDI-Device Identifier: 08717213054660
• UDI-Public: 08717213054660
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 189616
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1