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

Catalog Number 2033

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem Cancer (3262)

Event Type  malfunction  

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 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
• Type of Device: BRACHYTHERAPY SEEDS AND STRAND
• Manufacturer (Section D): ISOAID LLC; 7824 clark moody boulevard; port richey FL 34668 6709
• Manufacturer (Section G): ISOAID LLC; 7840 clark moody boulevard; port richey FL 34668 6709
• Manufacturer Contact: mary greenawalt ; 7824 clark moody boulevard; port richey, FL 34668-6709 ; 7278153262
• MDR Report Key: 5735349
• MDR Text Key: 47743497
• Report Number: 3003440305-2016-00001
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1