MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC KIT 1-LUMEN: 4.5 FR X 55CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-45541-HPK1A

Device Problem Break (1069)

Patient Problems Embolism (1829); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 08/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information requested from the user facility (doctor).No response and no additional information received at the time of this report.

Event Description

On 8/23, the doctor was inserting a single lumen picc.The sheath was placed in the patient's vein.She was peeling away the sheath and the peel away part of the sheath broke off, leaving the sheath in the patient with no securement.The sheath subsequently was lost in the patient's vasculature.The patient was sent down to vascular surgeon.A basilic vein cutdown was performed and the sheath was not found.The patient had a ct done and it was found that the sheath had embolized and was found in the patient's ventricle.During ir surgery, the sheath was retrieved from the patient's pulmonary artery.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

On (b)(6), the doctor was inserting a single lumen picc.The sheath was placed in the patient's vein.She was peeling away the sheath and the peel away part of the sheath broke off, leaving the sheath in the patient with no securement.The sheath subsequently was lost in the patient's vasculature.The patient was sent down to vascular surgeon.A basilic vein cutdown was performed and the sheath was not found.The patient had a ct done and it was found that the sheath had embolized and was found in the patient's ventricle.During ir surgery, the sheath was retrieved from the patient's pulmonary artery.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PICC KIT 1-LUMEN: 4.5 FR X 55CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9010551
• MDR Text Key: 159921991
• Report Number: 1036844-2019-00952
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K112896
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDC-45541-HPK1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 33 YR