MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CDC-45703-P1A

Device Problems Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that while the wire was being removed from the catheter, it would get stuck and could not be removed.One incident, the md pulled and the wire finally came out.There was no injury or consequence to the patient reported.The patient's condition is reported as "fine".Therapy was reported to have been delayed/interrupted due to the alleged defect.

Manufacturer Narrative

(b)(4).The customer returned one guide wire for evaluation.The catheter was not returned.The guide wire was unraveled and showed evidence of use.Visual examination revealed the guide wire is unraveled from the proximal weld and has multiple kinks in the guide wire body.The distal end of the guide wire has a gradual curve extending to the j-bend.The distal j-bend is undamaged.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 exposed proximal core wire tip is rounded, pinched and discolored at the point of separation.Both welds appeared full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The kinks in the guide wire body were measured at 36.5 and 38.5cm from the proximal weld.The guide wire begins curving 52cm from the proximal tip and extends to the distal tip.The guide wire core wire overall length measured 602mm which is within the specification; therefore no pieces appear to be missing.The outside diameter (od) of the guide wire was measured and was found to be within specification.A manual tug test confirmed that the distal weld was intact.Other remarks: a device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The instructions-for-use provided with this kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu states that if resistance is encountered when attempting to remove the spring wire guide after catheter placement, the spring wire guide may be kinked about the tip of the catheter within the vessel.In this circumstance, 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 was unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.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 (b)(4) 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 likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned.

Event Description

The customer reports that while the wire was being removed from the catheter, it would get stuck and could not be removed.One incident, the md pulled and the wire finally came out.There was no injury or consequence to the patient reported.The patient's condition is reported as "fine".Therapy was reported to have been delayed/interrupted due to the alleged defect.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 6708030
• MDR Text Key: 79907463
• Report Number: 3003737899-2017-00069
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: 13F16K0326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2016
• 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