MAUDE Adverse Event Report: ANGIODYNAMICS MINISTICK MICROPUNCTURE KIT MAX 5F X 10 CM ; DIALTOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Catalog Number 45-756

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/09/2019

Event Type  Injury  

Event Description

The pt came in for a mediport.The vein was accessed with a micropuncture kit.The sheath was left in place and a j wire was advanced down to the ivc.The mediport was placed in the chest in a subcutaneous pocket and tunneled underneath the skin.The sheath was pulled o exchange for the larger sheath and only the gray hub was present.There was no evidence of the white part of the sheath.It was not present subcutaneously.An exchange was made for another sheath and only 1 cm of it was inserted for a venogram.The sheath could not be visualized well and did not appear to be in the ivc.The sheath was removed manual pressure was held.The port was removed.The chest wound was closed and the neck puncture site was closed with sutures and dermabond.The pt was hemodynamically stable.She was transferred to the winthrop er.A chest xray was performed and the sheath was visualized in the right atrium and right ventricle.The pt was taken to interventional radiology where the sheath was able to be snared from the right groin.The pt was discharged in stable condition after a few hours of bedrest.

• Brand Name: MINISTICK MICROPUNCTURE KIT MAX 5F X 10 CM
• Type of Device: DIALTOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS
• MDR Report Key: 9104365
• MDR Text Key: 159849476
• Report Number: MW5089958
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 45-756
• Device Lot Number: 5497862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR