MAUDE Adverse Event Report: NUCLETRON B.V. VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	01/31/2019
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 been completed.
Event or Problem Description
The customer reported that the vaginal tube for the 25, 30 and 25 mm set will not stay locked in place.Unfortunately a patient's vaginal cuff was perforated when the vaginal tube became dislodged.
Event or Problem Description
The customer reported that the vaginal tube for the 25, 30 and 25 mm set will not stay locked in place.Unfortunately a patient's vaginal cuff was perforated when the vaginal tube became dislodged.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the reported information.The intrauterine tube has a diameter of 14 mm which implies that considerable force is required to penetrate/puncture patient tissue.This force most likely occurred when the patient was moved to the imaging room with the applicator fixated in the applicator clamp.The applicator was fixated with the ct/mr applicator clamp directly on the intra uterine tube instead of on the cylinder using the designated adapter (110778 - optional part) as per the user manual.Due to this the iu tube can be extended from the cylinder if it is not fixated adequately with the screw when the patient moves while being transferred to the image room.The cylinder and screws were not returned, it could not be determined if the clamping force was adequate or not.It is recommended to use the designated clamp adapter to fixate on the cylinder and not on the intra uterine tube when using the ct/mr applicator clamp.Patient movement must be avoided when the applicator is fixated in the clamp.The labelling cautions: to avoid excessive external forces.Therefore if this issue is applicator related, it is considered a use error.

• Brand Name: VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
• 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: 8377997
• Report Number: 9611894-2019-00001
• Device Sequence Number: 2326966
• Product Code: JAQ
• UDI-Device Identifier: 08717213022416
• UDI-Public: 08717213022416
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K111973
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1