MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 8" (20 CM); CATHETER, PERCUTANEOUS

Catalog Number ES-04701

Device Problems Bent (1059); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: medical doctor was performing the procedure according to ifu.The guidewire was bent and couldn't get in.The medical doctor took out another new product and finished the procedure.

Manufacturer Narrative

(b)(4)the customer returned an opened es-04701 set containing various components including a guide wire assembly for evaluation.None of the components showed any evidence of use.The guide wire was returned fully retracted within the advancer tube with the end cap secure.Visual examination of the guide wire did not reveal any defects or anomalies.The distal j-bend was undamaged and both welds were full and spherical.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The guide wire was functionally tested by advancing it through the catheter, dilator, arrow raulerson syringe (ars) and introducer needle.The guide wire advanced through each of the components with minimal resistance.Manual tug test confirmed both the distal and proximal welds are intact.A device history record review was performed on the guide wire and insertion components (ars and introducer needle) and no relevant manufacturing issues were identified.The customer report of a kinked guide wire could not confirmed through evaluation of the returned sample.No defects or anomalies were observed on the returned guide wire.(con't) other remarks: the guide wire met all relevant dimensional/functional requirements and a device history record review did not reveal any manufacturing related issues.No problem was found on the returned sample; therefore, no further action will be taken.

Event Description

The customer reports: md was performing the procedure according to ifu.The guidewire was bent and couldn't get in.The md took out another new product and finished the procedure.

• Brand Name: ARROW CVC SET: 14 GA X 8" (20 CM)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7533621
• MDR Text Key: 108897917
• Report Number: 3006425876-2018-00314
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Catalogue Number: ES-04701
• Device Lot Number: 71F17E1718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1