MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER, INTRODUCER

Catalog Number CDC-45552-VPS2

Device Problem Coiled (1098)

Patient Problems Pleural Effusion (2010); Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports no blue bulls eye was obtained.The inserter noted 2 "bumps" while inserting the picc, otherwise a normal insertion.Upon chest x-ray, the picc was noted to be coiled.A power flush was attempted to redirect the picc.The patient's condition worsened and repeat ct lungs showed bilateral fluid collections.There was concern for vessel injury/perforation at this point.The catheter was removed at some point and was not saved for testing, nor the vps stylet.Chest tubes were placed.It is reported that the patient is doing ok.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports no blue bulls eye was obtained.The inserter noted 2 "bumps" while inserting the picc, otherwise a normal insertion.Upon chest x-ray, the picc was noted to be coiled.A power flush was attempted to redirect the picc.The patient's condition worsened and repeat ct lungs showed bilateral fluid collections.There was concern for vessel injury/perforation at this point.The catheter was removed at some point and was not saved for testing, nor the vps stylet.Chest tubes were placed.It is reported that the patient is doing ok.

• Brand Name: ARROW CG+ PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Type of Device: CATHETER, INTRODUCER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7399573
• MDR Text Key: 104539493
• Report Number: 1036844-2018-00108
• 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: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 23F17K0238
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention