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 Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the user facility had a post insertion cxr (1 day after placement and bbe) that showed the picc in the ventricle.The user facility pulled picc back 5cm.No patient injury or complication reported.

Manufacturer Narrative

(b)(4).A sample was not returned for evaluation.The customer provided photographs.The photographs were reviewed by vps r and d.The data set was loaded onto a known good vps g4 system and a video was prepared for analysis of the data.The analysis of the data was performed by vps r and d.Vps r and d reported the investigation of this complaint was performed by reviewing the complaint report which included an x-ray of the catheter deep, x-ray of the catheter pulled back, the bbe report printout and the procedure dataset.During review of the procedure it was observed that the catheter was placed prior to turning on the vps g4 system.Upon placement of the catheter it then appears that the g4 system was turned on to verify tip location of the catheter.Section 7 of the arrow vps g4 device operator's manual steps through the recommended procedure for preparation, insertion and guidance starting at the peripheral insertion point.At the point the g4 system was turned on there was turbulent doppler flow that occurred throughout the procedure.As discussed in section 13 of the arrow vps g4 device operator's manual turbulent doppler flow is indicated by filled in peaks versus hollow peaks which are indicative of laminar flow.Turbulent flow would occur if the catheter were placed beyond the lower 1/3rd of the svc and in the ventricle.Vps r and d concluded the recommended insertion procedure per the operator's manual was not followed in this case by placing the catheter first and then turning on the vps g4 system to verify placement which could result in the catheter being placed to deep.The turbulent doppler flow was another indicator that the catheter could have been placed beyond the lower 1/3rd of the svc.The report the vps symbol was incorrect was not confirmed by evaluation of the returned case data set.A sample was not returned for analysis.Vps r and d reviewed the case data set.During review of the procedure it was observed that the catheter was placed prior to turning on the vps g4 system.Upon placement of the catheter it then appears that the g4 system was turned on to verify tip location of the catheter.Section 7 of the arrow vps g4 device operator's manual steps through the recommended procedure for preparation, insertion and guidance starting at the peripheral insertion point.At the point the g4 system was turned on there was turbulent doppler flow that occurred throughout the procedure.As discussed in section 13 of the arrow vps g4 device operator's manual turbulent doppler flow is indicated by filled in peaks versus hollow peaks which are indicative of laminar flow.Turbulent flow would occur if the catheter were placed beyond the lower 1/3rd of the svc and in the ventricle.Vps r and d concluded the recommended inser tion procedure per the operator's manual was not followed in this case by placing the catheter first and then turning on the vps g4 system to verify placement which could result in the catheter being placed to deep.The turbulent doppler flow was another indicator that the catheter could have been placed beyond the lower 1/3rd of the svc.User error caused or contributed to this event because the user did not follow the recommended insertion procedure per the operator's manual.An in service was requested to review the ifu recommended procedure for preparation, insertion and guidance starting at the peripheral insertion point and the ifu additional ecg and doppler information.

Event Description

The customer reports: the user facility had a post insertion cxr (1 day after placement and bbe) that showed the picc in the ventricle.The user facility pulled picc back 5cm.No patient injury or complication 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: 8850162
• MDR Text Key: 152914226
• Report Number: 1036844-2019-00854
• 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: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CDC-45052-VPS2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention