MAUDE Adverse Event Report: ARGON MEDICAL DEVICES OPTION ELITE RETRIEVABLE

Catalog Number 352506070E

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

No patient injury was reported.As of the date of this report, no surgical or medical intervention has been performed for retrieval of the inverted filter.No lot number was provided; therefore, a review of the batch records could not be conducted.No product was available for return in relation to this complaint according to the per form.The filter was left in the patient, and the deployment system were not returned.Additionally, no images were provided to argon quality for investigation, despite multiple requests.If additional information is received, this complaint will be updated as necessary.The exact root cause of the complaint could not be determined.However, it is possible that the operator noted resistance in the sheath.Per the ifu, if resistance is met, the user is to discontinue the procedure.

Event Description

Event details customer : the doctor placed option for the first time.He placed it in the jugular with the otw (over the wire) delivery.Because the dilator was over the filter, it stuck to the dilator when the doctor advanced it up.The filter was pushed down and it turned inside out.The filter was left inverted in the patient and another one was added on top of it.

• Brand Name: OPTION ELITE RETRIEVABLE
• Type of Device: OPTION
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5435009
• MDR Text Key: 38723248
• Report Number: 1625425-2015-00081
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 352506070E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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