MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW VASONOVA VPS G4 CONSOLE/ACCESSORIES; CATHETER ULTRASOUND VASCULAR

Model Number	IPN035976
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "vps g4 system was used during a picc insertion.The inserting clinician obtained a blue bullseye when the catheter was advanced only 10cm.The blue bullseye was reported to be sustained through the entire advancement of the picc, up to the 47cm measurement." no patient harm reported.The patient's condition is fine.An x-ray was obtained to confirm placement.
Additional Manufacturer Narrative
Qn#(b)(4).The reported issue "the inserting clinician obtained a blue bullseye when the catheter was advanced only 10cm.The blue bullseye was reported to be sustained through the entire advancement of the picc, up to the 47cm measurement" was confirmed by evaluation of returned vps g4 system s/n: (b)(6) with accessories.A visual examination revealed the ecg cable, sec cable, and remote control exhibited normal wear while all other returned items were in acceptable condition with no obvious external defects or anomalies observed.During functional testing using the returned cables, all steps passed, indicating the returned console was functioning as intended.Patient case (b)(6) was recorded and provided.Review of the case revealed the case started out with a yellow triangle for the 1st 1800 frames which indicates that there was insufficient signal for the system to determine blood flow.After the 1800 frames the system was able to obtain sufficient signal to determine blood flow.The intravascular ecg waveform throughout the case was not a normal sinus rhythm as there is a notched qrs complex, and as the catheter was advanced, a depressed s-t segment was observed.These abnormalities are indicative of previous myocardial damage.It was concluded with the 1800 frames of the yellow symbol, along with the cardiac abnormalities, the algorithm was not able to process information adequately to show proper placement of the tip of the catheter.A follow up confirmatory method was used appropriately by the clinician.The g4 device is indicated for use on patients with a normal sinus rhythm.A device history record review performed on the console did not reveal any manufacturing or servicing related issues.The probable cause of this issue is patient condition.No further action will be taken.Teleflex will continue to monitor and trend reports of this nature.
Event or Problem Description
The complaint is reported as: "vps g4 system was used during a picc insertion.The inserting clinician obtained a blue bullseye when the catheter was advanced only 10cm.The blue bullseye was reported to be sustained through the entire advancement of the picc, up to the 47cm measurement.".No patient harm reported.The patient's condition is fine.An x-ray was obtained to confirm placement.

• Brand Name: ARROW VASONOVA VPS G4 CONSOLE/ACCESSORIES
• Common Device Name: CATHETER ULTRASOUND VASCULAR
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14273961
• Report Number: 3003898360-2022-00146
• Device Sequence Number: 17619258
• Product Code: OBJ
• UDI-Device Identifier: 30801902129230
• UDI-Public: 30801902129230
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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 Model Number: IPN035976
• Device Catalogue Number: VPS-G4C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown