MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM; INTRODUCER, CATHETER

Catalog Number CDC-45052-VPS2

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Inserter report: picc line inserted.Pt v paced but able to calibrate.Line placed with bull's eye verification, however in setting of v pacing line, x-ray was obtained.Line noted to be in rt atrium and requested pullback of 6cm pulled back 4 cm post x-ray needed to pull back additional 2.Line was anticipated to be 42 cm internal and 3 external line was pulled back to 36 internal and 9 external.No delay in treatment reported.

Manufacturer Narrative

(b)(4).It was reported "picc line inserted.Pt v paced but able to calibrate.Line placed with bullseye verification, however in setting of v pacing line, xray was obtained.Line noted to be in rt atrium and requested pullback of 6cm pulled back 4 cm post xray needed to pull back additional 2 line was anticipated to be 42 cm internal and 3 external lie was pulled back to 36 internal and 9 external".A sample was not returned for review.A device history record review was performed and did not reveal any manufacturing related issues.A patient case dataset was provided.Vps r and d reviewed the procedure dataset to understand the procedure/environment conditions that took place at the time.The review of the complaint report indicated that the patient v paced but was able to calibrate.A review of the procedure dataset confirmed that the ecg rhythm presented as a v paced ecg signal during calibration.The arrow vps g4 device operators manual states in the indications for use section: "limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the p-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker drive rhythm in such patients, who are easily identifiable prior to central venous catheter insertion, the use of additional methods is required to confirm catheter tip locations." vps r and d concluded the case having presented as v paced during calibration required the use of an additional method to confirm catheter tip location as was ultimately done by the account with an x-ray confirmation.A probable cause of this issue could not be determined based on the information provided and without a sample.The report from the customer indicates the customer is aware of the "limiting but not contraindicated situations" for use of the vvps g4 system.However, the provision of an in service has been requested to review the "limiting but not contraindicated situations for this technique in patients where alterations of cardiac rhythm change the presentation of the p-wave".A probable cause of this issue could not be determined based on the information provided and without a sample.No further action will be taken.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Inserter report: picc line inserted.Pt v paced but able to calibrate.Line placed with bull's eye verification, however in setting of v pacing line, x-ray was obtained.Line noted to be in rt atrium and requested pullback of 6cm pulled back 4 cm post x-ray needed to pull back additional 2.Line was anticipated to be 42 cm internal and 3 external line was pulled back to 36 internal and 9 external.No delay in treatment reported.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10295028
• MDR Text Key: 201871030
• Report Number: 1036844-2020-00205
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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
• Device Operator: No Information
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CDC-45052-VPS2
• Device Lot Number: 23F19L0020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention