MAUDE Adverse Event Report: MICK RADIO-NUCLEAR INSTRUMENTS, INC. MICK SHIELDED DISPOSABLE MAGAZINE; MICK MAGAZINE

Model Number 0216-DS

Device Problem Failure to Discharge (1169)

Patient Problem Missed Dose (2561)

Event Date 02/24/2015

Event Type  Injury  

Event Description

During a prostate seed implant (ldr prostate brachytherapy) at (b)(6), it was reported that while using a muck magazine there was an incident reported to the eu complaint handling system.There were 3 seeds (out of 15 seeds in a magazine) that were not implanted per the dosimetry plan due to the 3 seeds not ejecting properly from the magazine.In an interview with the physician involved in the surgery, it was stated that the dosimetry was re-planned and the implant continued.After the implant was completed, it was identified via ct that there were 3 seeds not implanted.It was also reported that the pt was not injured nor was there med or surgical intervention required in the incident.Please note that the mick magazine is the delivery device for the radioactive seeds and remains outside the body while the seeds are implanted.It is an accessory to the implant.

• Brand Name: MICK SHIELDED DISPOSABLE MAGAZINE
• Type of Device: MICK MAGAZINE
• Manufacturer (Section D): MICK RADIO-NUCLEAR INSTRUMENTS, INC.; 521 homestead ave.; mount vernon NY 10550
• Manufacturer Contact: 521 homestead ave.; mount vernon, NY 10550 ; 9146673999
• MDR Report Key: 4658389
• MDR Text Key: 21551832
• Report Number: 2431392-2015-00001
• Device Sequence Number: 1
• Product Code: IWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0216-DS
• Device Catalogue Number: 0216-DS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other