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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM; INTRODUCER, CATHETER
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ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM; INTRODUCER, CATHETER Back to Search Results
Model Number IPN037300
Device Problem Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: line placed on (b)(6) 2021.Picc line placed without event and bulls eye obtained.Patient properly positioned at end of case for final tip placement/bulls eye.Xray taken on (b)(6) showed the line in the ventricle and requiring a 4cm pull back.No patient injury or complication reported.The patient's condition is reported as fine.
 
Event Description
The complaint is reported as: line placed on (b)(6) 2021.Picc line placed without event and bulls eye obtained.Patient properly positioned at end of case for final tip placement/bulls eye.Xray taken on (b)(6) showed the line in the ventricle and requiring a 4cm pull back.No patient injury or complication reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The complaint was reported as: line placed on (b)(6) 2021.Picc line placed without event and bulls eye obtained.Patient properly positioned at end of case for final tip placement/bulls eye.Xray taken on (b)(6) showed the line in the ventricle and requiring a 4cm pull back.A material sample was not returned for evaluation; however, the complainant provided a copy of the patient case data which was transferred to a video for analysis.Vps r and d performed an analysis of the data provided by the complainant and reported: the investigation of this complaint was performed by reviewing the complaint report and the saved procedure dataset , where the complaint was placed against the pre-loaded stylet (cdc-45052-vps2).The stylet used during the procedure was not returned for investigation.In reviewing the case data, it appeared the case went well and that the clinician followed the training by advancing the catheter/stylet into the right atrium and then pulling back for the maximum p-wave height.There was nice p-wave elevation along with the blue bullseye.While the chest x-ray read in the ventricle, there is no indication from the case review that the catheter/stylet was placed that deep.An indication of being in the ventricle would be an inverted p-wave which was not observed at any point during the case review.Vps r and d concluded, with the information available to investigate the catheter placement it was not possible to determine any abnormal system behavior or stylet failure that would have led to the deep placement of the catheter.Patient position during chest x-ray could have a temporary impact on catheter location and should be considered during x-ray confirmation.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 analysis of the information provided and without a material sample.Teleflex will continue to monitor and trend for reports of this nature.
 
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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 Key11417609
MDR Text Key243759642
Report Number1036844-2021-00039
Device Sequence Number1
Product Code DYB
UDI-Device Identifier30801902120756
UDI-Public30801902120756
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date01/31/2022
Device Model NumberIPN037300
Device Catalogue NumberCDC-45052-VPS2
Device Lot Number23F20J0198
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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