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 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: the snapshots taken do not correlate to the actual position of the picc on chest x-ray.The patient was measured at 37cm.There was a good ecg trace and peak p wave at 40cm.As the picc was pulled back to check for p wave getting smaller, the p wave became biphasic at 38cm and then normal at 36cm.The picc was advanced back to 40cm and chest x-ray confirmed the distal tip of picc placed correctly just below the lower third of svc.No patient harm was reported, the patient's condition is reported as fine.

Manufacturer Narrative

(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.

Event Description

The complaint is reported as: the snapshots taken do not correlate to the actual position of the picc on chest x-ray.The patient was measured at 37cm.There was a good ecg trace and peak p wave at 40cm.As the picc was pulled back to check for p wave getting smaller, the p wave became biphasic at 38cm and then normal at 36cm.The picc was advanced back to 40cm and chest x-ray confirmed the distal tip of picc placed correctly just below the lower third of svc.No patient harm was reported, the patient's condition is reported as fine.

• Brand Name: ARROW VPS RHYTHM MONITOR BUNDLE
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11094616
• MDR Text Key: 224857718
• Report Number: 3011137372-2020-00295
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• 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
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1