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

Model Number	189623-01
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	Blood Loss (2597); No Information (3190)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A prostate brachytherapy procedure was performed by the hospital.Eighteen needles were placed in the prostate and the patient experienced bleeding.The hospital performed two surgeries to control the bleeding in the bladder and gave a blood transfusion.The investigation of this case is still on-going by elekta whom are awaiting further details from the hospital.Elekta is investigating what the relationship is between the bleed and the usage of the proguide needles and what procedure did the hospital follow.This case is the first case of this kind reported to elekta.
Event or Problem Description
Customer reported that they ordered proguide sharp needles for prostate brachytherapy but they instead received proguide round needles for prostate brachytherapy.The patient was bleeding during the treatment.The customer suggested a connection between the bleeding and the usage of the proguide needles.
Additional Manufacturer Narrative
E2 updated.E3 updated.H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the reported information.It was ascertained that due to a human error, an incorrect order was placed in the ordering software, and round proguide needles were delivered instead of the sharp needles as requested by the customer.There are no indications that the patient injury is related to the use of a mix of round and sharp proguide needles during the application.The issue could not be investigated further because no detailed information regarding this application has been received from the hospital, despite a number of requests.

• Brand Name: PROGUIDE NEEDLE SET
• Common Device Name: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON B.V.; waardgelder 1; 3905 TH; NL 3905 TH
• MDR Report Key: 9123048
• Report Number: 9611894-2019-00002
• Device Sequence Number: 13555351
• Product Code: JAQ
• UDI-Device Identifier: 08717213020450
• UDI-Public: (01)08717213020450
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K060349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: Health Professional
• Device Model Number: 189623-01
• Device Lot Number: 60898539
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention