MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"; CATHETER INTRAVASCULAR THERAP

Catalog Number CDC-45703-P1A

Device Problems Unraveled Material (1664); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the doctor attempted placement and the guidewire was difficult to pass.Tip was validated using ultrasound.The doctor was unable to get catheter to pass.The distal portion of the wire began to coil.The entire wire and catheter were removed.A new kit was used.Insertion and passage was completed without complications.

Event Description

The customer reports: the doctor attempted placement and the guidewire was difficult to pass.Tip was validated using ultrasound.The doctor was unable to get catheter to pass.The distal portion of the wire began to coil.The entire wire and catheter were removed.A new kit was used.Insertion and passage was completed without complications.

Manufacturer Narrative

Qn#(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.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8178409
• MDR Text Key: 130917178
• Report Number: 1036844-2018-00320
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• 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: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1