MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW(R) VPS(R) ACCESS KIT; CATHETER, ULTRASOUND, INTRAVAS

Catalog Number	VPS-0072-BPK
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: low amplitude and inconsistent doppler waveform and unable to get bullseye.Chest x-ray was needed to confirm picc position.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: low amplitude and inconsistent doppler waveform and unable to get bullseye.Chest x-ray was needed to confirm picc position.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
(b)(4).The reported issue "new wire had low amplitude doppler waveform that did not resolve with lots of flushing" was not confirmed by evaluation of the returned vps g4 g1+ legacy stylet assembly.A visual examination did not reveal any obvious defects or anomalies and the encapsulated transducer was intact.The sample was connected to a known good vps g4 system, and a simulated procedure was performed.A clear doppler signal was visually and audibly displayed during the flush and the procedure.The stylet was electrically tested for sensitivity per the requirements of product specification, which requires a minimum 600 mv peak-to-peak echo signal.The testing was performed per the instructions contained in pulser receiver and stylet holder.The peak-to-peak echo signal measured 1467 mv, indicating the stylet has acceptable doppler functionality.For capacitance of the coaxial cable, process specification states, the acceptable range for capacitance of the coaxial cable is = 185pf and = 250pf.Using smart tweezers by making contact between pins 1 and 6, the capacitance of the coaxial cable measured 207pf, indicating no issue with the coaxial cable.The reported issue was not reproduced.No problem was found with the doppler functionality of the returned stylet.A device history record review performed on the stylet did not reveal any manufacturing related issues.The reported issue was not reproduced.No problem was found with the doppler functionality of the returned stylet.No further action will be taken.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW(R) VPS(R) ACCESS KIT
• Common Device Name: CATHETER, ULTRASOUND, INTRAVAS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18215405
• Report Number: 9680794-2023-00919
• Device Sequence Number: 14880263
• Product Code: OBJ
• UDI-Device Identifier: 10801902145779
• UDI-Public: 10801902145779
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: 05/31/2024
• Device Catalogue Number: VPS-0072-BPK
• Device Lot Number: 33F23D0846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown