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

Catalog Number RA-04220

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The preliminary evaluation of the returned device indicates spring wire guide/catheter resistance - kinked.

Event Description

The customer reports the catheter kinked over the wire.

Manufacturer Narrative

(b)(4).The customer returned one arterial catheterization device (without the catheter) and the lidstock from a ra-04220 kit for evaluation.The spring-wire guide (swg) was kinked toward the distal end.Microscopic examination confirmed the kink and revealed offset coils and biological material at the same location as the kink.The swg was kinked 18 mm from the distal end of the swg.The outer diameter of the swg was measured and was found to be within specification.A device history record review was performed and no relevant findings were identified.The instructions-for-use (ifu) that are packaged with this product suggest that the catheterization device be removed by firmly holding the introducer needle hub in position and advancing the catheter forward, with a slight rotating motion, over the swg into the vessel.The ifu also warns not to retract the swg against edge of needle while in vessel to minimize the risk of swg damage.The customer reported issue of the arterial catheter and swg kinking during use was confirmed during the complaint investigation.The returned catheterization device was visually examined and the swg was found to be kinked toward the distal tip.The catheter was not returned for evaluation.Dimensional inspection was performed on the swg and no issues were identified.A device history record review was performed and no relevant findings were identified.Without the catheter, a probable cause of this issue could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports the catheter kinked over the wire.

• 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: 7510839
• MDR Text Key: 108228475
• Report Number: 9680794-2018-00123
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: RA-04220
• Device Lot Number: 14F17M0066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1