MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-45703-XP1A

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was received by the manufacturer, but the investigation results are pending at the time of this report.

Event Description

The customer alleges that the spring wire guide would not pass the entire way through the cvc.The wire is not coming apart, just bunching up in the procedure.Therapy was not delayed.

Manufacturer Narrative

(b)(4).The customer did not return the actual sample; however, they did return a representative sample kit from lot#23f17b0357.No defects or anomalies were observed on the catheter or guide wire from the representative kit.The representative sample passed all relevant dimensional requirements.The guide wire was also advanced through the other insertion components with minimal resistance.All components functioned as expected.A manual tug test performed on the representative sample confirmed both the distal and proximal welds are intact.A device history record review was performed on the guide wire and catheter and no relevant findings were identified.Other remarks: the instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu states that if resistance is encountered when attempting to remove the spring wire guide after catheter placement, the spring wire guide may be kinked about the tip of the catheter within the vessel.In this circumstance, withdraw the catheter relative to the spring wire guide about 2-3cm and attempt to remove the spring wire guide.If resistance is again encountered, remove the spring wire guide and catheter simultaneously.Complaint verification testing could not be performed as the actual complaint sample was not returned for analysis.A representative sample was returned and met all relevant visual, dimensional and functional requirements.A dhr review was performed and no relevant findings were identified.Without the actual complaint 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 alleges that the spring wire guide would not pass the entire way through the cvc.The wire is not coming apart, just bunching up in the procedure.Therapy was not delayed.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6669591
• MDR Text Key: 78473993
• Report Number: 1036844-2017-00247
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F17B0357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1