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

Catalog Number AK-45703-P1A

Device Problems Material Frayed (1262); Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The customer reports the guidewire bent and when pulling the wire, it was difficult and frayed.

Manufacturer Narrative

(b)(4).The customer returned a single guide wire and lidstock for evaluation.The guide wire was unraveled and showed evidence of use.Visual examination revealed the guide wire is unraveled from the proximal weld and has a multiple kinks towards the distal end of guide wire body.The distal j-bend core wire is intact.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld and that the weld was present at the end of the coil wire.The distal weld appeared full and spherical.The kinks in the guide wire body was measured at 40 mm, 105 mm and 200 mm from the distal tip.The broken core wire measured 601 mm in length, which is within the specification of 596-604 mm per product drawing; therefore no pieces of the core wire appear to be missing.The outside diameter was also within specification.The undamaged distal end of the guide wire was able to advance through a lab inventory 18ga introducer needle and arrow raulerson syringe with minimal resistance.The proximal end could not be tested due to the damage.A manual tug test confirmed that the distal weld was intact.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.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire was damaged was confirmed through examination of the returned sample.The guide wire was unraveled and the core wire was broken adjacent to the proximal weld.Dimensional inspection did not reveal any evidence of a manufacturing related issue.A device history record review was performed based on sales history with no relevant findings.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, 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 guidewire bent and when pulling the wire, it was difficult and frayed.

• 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 INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8143055
• MDR Text Key: 129648700
• Report Number: 3003737899-2018-00176
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: AK-45703-P1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/17/2019
• 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