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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VPS RHYTHM ECG ONLY PACK WITHOUT JOHANS; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW VPS RHYTHM ECG ONLY PACK WITHOUT JOHANS; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number RHY-100-ECGO
Device Problem Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Potential lot number: 13f19d0025, 13f18a0389, 13f19d0025, 13f19d0025, 13f19j0416.
 
Event Description
The inserter measured 36cm on the device and placed the line to 37cm where a biphasic peak was observed on the p-wave, then came back to 36cm.There seemed to be some artifact interfering with the final trace , but the inserter was satisfied that she could read through it.The cxr it was showed the picc was only into the 2nd intercostal space and the line was advanced to the hub at 40cm.
 
Manufacturer Narrative
Qn#(b)(4).The report "catheter tip location incorrect" was not confirmed since the sample was not returned for review.A device history record review was performed and did not reveal any manufacturing related issues.However, this complaint is one of eighteen associated complaints filed at the same time for "it is unknown why the trace showed an increase on the p-wave when it was not in the lower 1/3 of the svc", or in other words "clinicians reported that catheter tip placement when using the vps rhythm device does not correlate to confirmatory chest x-rays".Each of the complaints was accompanied by a photo of the tip confirmation checklist for the procedure being performed.A material sample was not returned for any of the complaints.No copies of the chest x-rays were provided for review.The sr.Global strategic clinical marketing manager reviewed all eighteen complaints.The sr.Global strategic clinical marketing manager concluded, based on the observations of the tip confirmation checklists, it is possible that when using confirmatory chest x-rays, appropriate techniques were not followed to remove cxr variables.These variables include keeping the patient in the same p osition as when the catheter was placed, keeping the head of the bed in the same position as when the catheter was placed, having the chest x-ray tube at a 90 degree angle towards the patient and the patient flat, and having radiology read each confirmatory chest x-ray in the same manner.These variables are well documented in published clinical studies.It is recommended that clinical education be provided to the clinicians managing the account.A corrective action is not required at this time.However, based on the information provided by the sr.Global strategic clinical marketing manager, the probable root cause is user error -unintentional - clinician technique.Based on the recommendation of the sr.Global strategic clinical marketing manager, an in service is being requested to review appropriate techniques to remove cxr variables.
 
Event Description
The inserter measured 36cm on the device and placed the line to 37cm where a biphasic peak was observed on the p-wave, then came back to 36cm.There seemed to be some artifact interfering with the final trace , but the inserter was satisfied that she could read through it.The cxr it was showed the picc was only into the 2nd intercostal space and the line was advanced to the hub at 40cm.
 
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Brand Name
ARROW VPS RHYTHM ECG ONLY PACK WITHOUT JOHANS
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9820254
MDR Text Key183007508
Report Number9680794-2020-00144
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberRHY-100-ECGO
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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