MAUDE Adverse Event Report: ISOAID LLC ISOAID ADVANTAGE STRAND; BRACHYTHERAPY SEEDS AND STRAND

Catalog Number	2033
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Cancer (3262)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in process.Once the investigation is complete, a supplemental report will be filed.The information provided by isoaid represents all of the known information at this time.
Event or Problem Description
Two brachytherapy needles (needles 2 and 15) failed to deploy during the brachytherapy implant procedure.The order totaled 20 advantage strands with 67 seeds; the total seeds which were not delivered was nine.The patient was planned to receive 100% of the dose to 43 cc.Due to the inability to implant the two strands containing 9 seeds, the initial implant covered 39.28 cc with 100% of the dose.The patient was sent home and rescheduled to receive a second implant procedure.An additional 20 seeds were ordered by and supplied to the user facility and the rescheduled procedure occurred nine days after (b)(6).The second procedure was performed to complete the original treatment dose prescription.The treatment efficacy was delayed since the patient was subjected to a second procedure to assure a correct treatment dose.A quality assurance investigation is underway.

• Brand Name: ISOAID ADVANTAGE STRAND
• Common Device Name: BRACHYTHERAPY SEEDS AND STRAND
• Manufacturer (Section D): ISOAID LLC; 7824 clark moody boulevard; port richey FL 34668 6709
• MDR Report Key: 5735349
• Report Number: 3003440305-2016-00001
• Device Sequence Number: 451801
• Product Code: KXK
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/14/2016

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 Expiration Date: 06/03/2016
• Device Catalogue Number: 2033
• Device Lot Number: 201641966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2016
• Initial Report FDA Received Date: 06/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1