MAUDE Adverse Event Report: NUCLETRON MICROSELECTRON MHDR DIGITAL; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number DIGITAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 07/10/2014

Event Type  Injury  

Event Description

Information from the nrc report: a patient undergoing high dose rate brachytherapy using ir-192 was prescribed 700 cgy per fraction and only received 700 cgy to 60% of the planned volume.The patient was scheduled for two treatments.The first treatment was successfully administered to the patient on (b)(6) 2014.When the patient returned for the second treatment on (b)(6) 2014 the hdr afterloader was loaded with the treatment plan for the original treatment instead of the second treatment.This resulted in the patient not receiving the full prescribed treatment.The licensee discovered the problem during an audit when the number of catheters did not match.There are no adverse health effects expected as a result of this treatment.

Manufacturer Narrative

Event caused by user.Additional information requested from hospital.Device not returned to the manufacturer.

Manufacturer Narrative

Event caused by user.No further information obtained from the customer.

• Brand Name: MICROSELECTRON MHDR DIGITAL
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON; waardgelder 1; veenendaal, ; NL
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 4116601
• MDR Text Key: 4702172
• Report Number: 9611894-2014-00001
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIGITAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other