MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 2-L 7 FR X 16 CM ANTIMICROBI; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-45703-XP1A

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the doctor attempted to place a central line in the left ij and the swg (spring wire guide) bent 90 degrees in the tissue of the patient and the dilator was not very good.No patient injury or consequence.The patient's condition is reported as fine.Therapy was not delayed/interrupted.

Manufacturer Narrative

(b)(4).Catalog # corrected to cdc-45703-xp1a.The customer returned a guide wire assembly for evaluation.The guide wire was returned within the advancer tube and showed evidence of use.Neither the product lid stock nor any other components were returned.The guide wire was observed to be kinked towards the distal end of the body.The distal j-bend was slightly deformed but intact.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.Dried blood was observed on the guide wire body indicating use.The guide wire was kinked 25 mm from the distal tip.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle (as is supplied in kit cdc-45703-xp1a) to functionally test the guide wire.Slight resistance was met while passing the kinked portion of the guide wire through the insertion components.A manual tug test confirmed that both the distal and proximal welds were intact.Other remarks: the instructions-for-use (ifu) provided with this kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked 25 mm from the distal tip.The returned guide wire met all relevant dimensional requirements.Based on the condition of the guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports that the doctor attempted to place a central line in the left ij and the swg (spring wire guide) bent 90 degrees in the tissue of the patient and the dilator was not very good.No patient injury or consequence.The patient's condition is reported as fine.Therapy was not delayed/interrupted.

• Brand Name: ARROW PI CVC KIT: 2-L 7 FR X 16 CM ANTIMICROBI
• 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: 6908636
• MDR Text Key: 88012928
• Report Number: 1036844-2017-00352
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1