MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-1/2" ;; WIRE, GUIDE, CATHETER

Catalog Number RA-04120

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "doctor faced difficulty to transverse the device through skin at puncture site to get radial arterial access.Catheter assembly gets curled up.Guide wire gets twisted/kink".It is reported that no intervention was required.

Manufacturer Narrative

Qn#(b)(4).The customer did not return the sample; however, two videos were provided for evaluation.The videos showed an arterial line insertion.When the guide wire was removed from the catheter, it was observed to be kinked.However, full visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit cautions the user, "if resistance is encountered while advancing spring-wire guide do not force feed.Warning: do not retract spring-wire guide against edge of needle while in vessel to minimize the risk of spring-wire guide damage".The customer report of a kinked guide wire was confirmed by inspection of the customer supplied videos.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "doctor faced difficulty to transverse the device through skin at puncture site to get radial arterial access.Catheter assembly gets curled up.Guide wire gets twisted/kink".It is reported that no intervention was required.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-1/2"
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9659434
• MDR Text Key: 177594245
• Report Number: 9680794-2020-00061
• 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: 01/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: RA-04120
• Device Lot Number: 14F18C0284
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.; UNKNOWN.