MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CV-26702-E

Device Problems Kinked (1339); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "there was a technical problem during the insertion of the cvc.The folding of the guide wire in several places cause of lack of possibility of insertion of the catheter.After replacing the set was possible to continue the insertion of the catheter.".

Manufacturer Narrative

(b)(4).The customer returned one guide wire for evaluation.The catheter was not returned.The guide wire was separated and showed evidence of use.Visual examination revealed the guide wire is separated from the proximal weld and is kinked/distorted in several locations along the body.The guide wire body contains one severe kink at the center of the guide wire where the proximal coil wire has separated from the remaining spring coil.The separated proximal coil wire was returned and does not show significant unraveling.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 tapered and discolored at the point of separation.The distal j-bend of the guide wire was kinked but intact.Both welds appeared full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The major kinks in the guide wire body were measured at 2.5, 23.4, 39.1 and 39.5cm from distal weld.The separated coil wire measured 20.8cm in length.The core wire overall length could not be accurately measured due to the severe kink in the guide wire body.The approximate overall length of the core wire was found to be within specification.Other remarks: the outside diameter (od) of the guide wire was also found to be within specification.A manual tug test confirmed that the distal weld was intact.A device history record review was performed on the guide wire and the 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 2-3 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 core wire was broken adjacent to the proximal weld and the proximal coil wire was separated from the guide wire body.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 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

It was reported that "there was a technical problem during the insertion of the cvc.The folding of the guide wire in several places cause of lack of possibility of insertion of the catheter.After replacing the set was possible to continue the insertion of the catheter.".

• Brand Name: ARROW CVC SET: 2-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6706082
• MDR Text Key: 79800191
• Report Number: 3006425876-2017-00222
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

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: 10/31/2018
• Device Catalogue Number: CV-26702-E
• Device Lot Number: 71F16M0594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• 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
• Patient Age: 66 YR
• Patient Weight: 90