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 Sticking (1597); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that when the doctor tried to remove the guidewire, it became stuck.After several attempts, the guidewire was removed but was unraveled.

Manufacturer Narrative

(b)(4).The customer returned a single unraveled guide wire for evaluation.The guide wire showed evidence of use in the form of dried blood.No other components were returned.Visual examination revealed the guide wire is unraveled from the proximal weld and is kinked at the center of the body.The core wire distal j-bend was undamaged.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.The exposed proximal core wire tip is pinched and discolored at the point of separation.Both welds were present and appeared full and spherical.The kink in the guide wire body was measured at 266mm from the proximal tip.The broken core wire measured 603mm in length, which is within specification; therefore no pieces of the core wire appear to be missing.The outer diameter of the guide wire was also found to be within specification.The undamaged distal end of the guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed that the distal weld was intact.(con't) other remarks: the customer did not supply a lot number; however, a potential lot number was determined from a sales history review for this customer.A device history record review was performed on the potential lot number of the catheter and insertion components and no relevant manufacturing issues 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 2-3cm 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 unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guide wire met all functional/dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.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 11070:1999 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 operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer alleges that when the doctor tried to remove the guidewire, it became stuck.After several attempts, the guidewire was removed but was unraveled.

• 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
• 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: 6849190
• MDR Text Key: 85154779
• Report Number: 1036844-2017-00347
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1