MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW SPRING WIRE GUIDE COMPONENT; WIRE GUIDE CATHETER

Catalog Number AW-04018

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information requested regarding patient condition.No additional information received at the time of this report.

Event Description

Dr.(b)(6) plaint to implant spring wire arrow for baby in nicu after open product look good but when try to insert into aximed 24 cannot inserted because guide wire feels rusty then doctor decided to change with new device batch 14f1880280 apparently same thing happens and procedure is stopped.

Manufacturer Narrative

Qn#(b)(4).The customer returned one guide wire and lidstock for evaluation.Visual examination revealed the guide wire had one distinct kink towards the middle of the guide wire body.Both welds were observed to be full and spherical.No other defects or anomalies were found on the returned device.No rust was observed on the guide wire.The kink in the guide wire measured 156mm from the distal end.The overall length and outer diameter of the guide wire were measured and were found to be within specification.The guide wire was advanced through the returned catheter, an inventory ars, and needle to functionally check the guide wire.The guide wire passed through all components with minimum resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A dhr review was completed on product lot returned with no relevant findings.The ifu provided with this kit warns the user "do not cut spring-wire guide to alter length.Do not withdraw spring wire guide against needle bevel to minimize the risk of possible severing or damaging of spring wire guide".The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked towards the middle of the guide wire body.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Dr.Eka plaint to implant spring wire arrow for baby in nicu after open product look good but when try to insert into aximed 24 cannot inserted because guide wire feels rusty then doctor decided to change with new device batch 14f1880280 apparently same thing happens and procedure is stopped.The patient condition is reported as "fine".

• Brand Name: ARROW SPRING WIRE GUIDE COMPONENT
• Type of Device: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8768507
• MDR Text Key: 150297403
• Report Number: 9680794-2019-00249
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

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 Catalogue Number: AW-04018
• Device Lot Number: 14F1880280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 DA