MAUDE Adverse Event Report: ARROW INC. ARROW GUIDE WIRE; CATHETER GUIDEWIRE

Catalog Number HOSP # 16743

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2016

Event Type  malfunction  

Event Description

Guide wire for arterial line malfunctioned.It is believed the guide wire was thicker than usual.Wire also did not straighten when it was pulled as it should.Another was pulled was stock, second wire was easier to use as it was not as thick but it still did not pull straight.Delay in treatment due to obtaining new guide wire.Second guide wire was used.Didn't work as it should have per user but was still able to work without causing harm to patient.

• Brand Name: ARROW GUIDE WIRE
• Type of Device: CATHETER GUIDEWIRE
• Manufacturer (Section D): ARROW INC.; 2400 bernville rd. ; reading PA 19605
• MDR Report Key: 7013823
• MDR Text Key: 91914907
• Report Number: MW5073222
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/06/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: HOSP # 16743
• Device Lot Number: 13F16K0037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 52