ATRIEVE VASCULAR SNARE KIT 7FR
Received Feb 28, 2023 · Event occurred Dec 21, 2022
Report 0001625425-2023-00976 · MDR key 16454398
Device
Generic name
Atrieve Vascular Snare Kit
Manufacturer
Argon Medical DevicesModel number
382007030Catalog number
382007030
Lot number
11374942
Product problems
- No Apparent Adverse Event
- Activation Failure
- No Apparent Adverse Event
- Activation Failure
Patient
Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.
Description of Event or Problem
THE FILTER DID NOT OPEN AFTER RELEASE(CC# (B)(4), AND WAS TAKEN OUT WITH OUR THREE-RING TRAP, AND ADDITIONAL EQUIPMENT NEEDED TO BE COMPENSATED.
Additional Manufacturer Narrative
A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS FOR THIS LOT WAS CONDUCTED, AND NO DEVIATIONS AND NON-CONFORMANCES WERE RECORDED. AFTER THIRD NOTIFICATION, SAMPLE WAS NOT RETURNED TO ARGON. THE COMPLAINT WAS CLOSED. NO CORRECTIVE REQUIRED AT THIS TIME. IF THE SAMPLE IS RETURNED AT A FUTURE DATE, THIS COMPLAINT MAY BE REOPENED FOR FURTHER EVALUATION AT THAT TIME.
Description of Event or Problem
THE FILTER DID NOT OPEN AFTER RELEASE (CC#: 14855), AND WAS TAKEN OUT WITH OUR THREE-RING TRAP, AND ADDITIONAL EQUIPMENT NEEDED TO BE COMPENSATED.