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

Catalog Number CDC-45703-XP1A

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the wires have been kinking and difficult to thread.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned a guide wire and straightener tube for evaluation.The guide wire was observed to have a three distinct kinks throughout the guide wire body.The distal j-bend was intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The kink in the guide wire were located 28mm, 168mm and 243mm 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 an inventory ars and needle to functionally check the guide wire.The guide wire passed through all components with minimum resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with the 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 throughout the guide wire body.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, it was determined that unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports the wires have been kinking and difficult to thread.The patient's condition is reported as fine.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8339738
• MDR Text Key: 136158302
• Report Number: 1036844-2019-00125
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F18E0147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1