MAUDE Adverse Event Report: NUCLETRON B.V. FLEXITRON HDR; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number	136149
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.A highly unlikely chain of events has been identified in which the internal source cable guide displacement can cause incorrect source cable positioning.For this to occur, all of the following conditions need to be met simultaneously: both internal guiding tubes for the check cable and source cable are defective.The obstruction in the cable path is not detected by the check cable.The obstruction in the cable path occurs after all channels passed the check cable checks.In addition, it is improbable that this error condition would not have been noticed during the mandatory safety, performance and functional tests that are performed during each source exchange or planned maintenance: · the cable obstructions detection circuits tests.· transfer tube connection test.· cable alignment verification done after these tests.This issue could cause treatment interruption or in a very unlikely chain of event, incorrect source positioning.An ifsn and ifsm will be released and contains instructions on how to inspect the flexitron internal cable guides.
Event or Problem Description
One customer complaint has been reported from the field concerning a system in which the internal check cable guide mechanism failed.Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged.
Additional Manufacturer Narrative
Updated as not ticked previously.

• Brand Name: FLEXITRON HDR
• 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: 9309326
• Report Number: 9611894-2019-00003
• Device Sequence Number: 559732
• Product Code: JAQ
• UDI-Device Identifier: 08717213051126
• UDI-Public: 08717213051126
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K070574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 136149
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1