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 3-lumen catheter and guide wire for evaluation.The guide wire was advanced through the distal extension line and the entire body of the catheter.The components showed evidence of use in the form of dried blood.No other components were returned.The guide wire was removed from the catheter and visual examination revealed the guide wire is unraveled from the proximal weld and is kinked/distorted in several locations along the body.The distal j-bend of the guide wire is undamaged.The returned catheter shows evidence of use but no obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld, although not directly at the weld point.A small portion of the core wire (1 mm) was attached to the proximal weld.The exposed core wire tips are pinched at the point of separation.Both welds were present and appeared full and spherical.Microscopic examination of the catheter did not reveal any defects or anomalies.The major kinks in the guide wire b ody were measured at 212, 280, 294 and 301mm from the proximal tip.The core wire attached to the proximal weld measured 600mm in length and the core wire attached to the distal weld measured 1mm in length.The accumulated length of 601mm is within the specification of 596-604mm; therefore, no pieces of the core wire appear to be missing.The outer diameter of the guide wire and the catheter body length were also found to be within specification.The catheter product drawing specifies that "0.035in diameter spring wire guide must pass freely thru distal lumen #1 from distal tip to hub without restriction." a lab inventory 0.035" guide wire (measured 0.847mm) passed through the distal extension line and catheter body of the returned catheter with minimal resistance.A manual tug test confirmed that the distal weld was intact.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 2-3 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 unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guide wire and catheter 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: 6849205
• MDR Text Key: 85157809
• Report Number: 1036844-2017-00348
• 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?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1