MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VPS RHYTHM MONITOR BUNDLE; CATHETER INTRAVASCULAR THERAPE

Model Number IPN037371

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer reports "unreliable / inaccurate picc tip positioning's using the ecg.The catheter to be adjusted post insertion by at least 3 cm i.E.The ecg placed the lines short even though we had what looked like a satisfactory ecg." no patient harm reported.

Event Description

Customer reports "unreliable / inaccurate picc tip positioning's using the ecg.The catheter to be adjusted post insertion by at least 3cm i.E.The ecg placed the lines short even though we had what looked like a satisfactory ecg." no patient harm reported.

Manufacturer Narrative

Qn#(b)(4).The report there was a correlation issue between the internal ecg waveform and the confirming xray was not confirmed since the sample was not returned for review.A photograph of some snapshots of the ecg signal was provided by the complainant.The event details and photo were reviewed.It is possible that they were threading very quickly and there was a delay in the readings on the screen; although that could not be confirmed without other evidence.It should be noted, the vps rhythm device does not record the entire picc placement procedure therefore a review of the case is not possible.A device history record review was performed and did not reveal any manufacturing related issues.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.

• Brand Name: ARROW VPS RHYTHM MONITOR BUNDLE
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11156379
• MDR Text Key: 226329635
• Report Number: 3011137372-2021-00010
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K160925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

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: Health Professional
• Device Model Number: IPN037371
• Device Catalogue Number: RHY-100-MTRB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1