MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SCORPIONX PORTAL VEIN ACCESS SET; SCORPION PORTAL VEIN ACCESS SET

Model Number	TPS006
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
While making passes with the scorpion x needle¿the tech noticed that the peek catheter was shorter than normal and not able to cover the needle tip.That¿s when we all realized that the peek catheter must have been sheared off during pass attempts in the liver.Dr hall was able to verify that the portion of the peek catheter was still in the patients liver parenchyma via fluoroscopy.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.Second notification send to the customer on (b)(6)and customer requested safety box.Customer requested safety box was directly shipped to the flagstaff medical center.Third request was sent on (b)(6).After third notification, the sample was not returned for evaluation, additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence this complaint could not be confirmed.The complaint was closed and cannot perform any further evaluation at this time.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.
Event or Problem Description
While making passes with the scorpion x needle¿the tech noticed that the peek catheter was shorter than normal and not able to cover the needle tip.That¿s when we all realized that the peek catheter must have been sheared off during pass attempts in the liver.Dr hall was able to verify that the portion of the peek catheter was still in the patients liver parenchyma via fluoroscopy.

• Brand Name: SCORPIONX PORTAL VEIN ACCESS SET
• Common Device Name: SCORPION PORTAL VEIN ACCESS SET
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 14742823
• Report Number: 0001625425-2022-01024
• Device Sequence Number: 14045226
• Product Code: DYB
• UDI-Device Identifier: 00886333225729
• UDI-Public: 00886333225729
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K213002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 10/07/2024
• Device Model Number: TPS006
• Device Catalogue Number: TPS006
• Device Lot Number: 11388807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown