MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 22 GA X 1-3/8"; WIRE GUIDE, CATHETER

Catalog Number RA-04122

Device Problem Kinked (1339)

Patient Problem Hematoma (1884)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial triage evaluation of the returned device indicates a kink in the device.

Event Description

The customer alleges that the spring wire guide was difficult to remove.Gentle removal of the device was successful and resulted in a hematoma at the insertion site.

Manufacturer Narrative

(b)(4).The customer returned a radial artery catheterization device consisting of a spring wire guide (swg), an advancer tube, a needle, and a catheter.The swg was fully advanced through the advancer tube.The catheter had been advanced down the needle approximately 3.5cm.The swg was protruding 1mm from the end of the catheter.Under microscopic examination, the catheter body had been punctured by the needle just below the hub of the catheter.The upper half of the catheter body was crumpled.Functional testing could not be performed due to the damage of the device.A device history record (dhr) was performed and no manufacturing related issues were found.The instructions for use (ifu) provided with the set describes a suggested procedure for inserting the catheter.The instructions direct the user to firmly hold the introducer needle hub in position and advance the catheter forward with a slight rotating motion.The instructions caution "do not reinsert needle into catheter to minimize risk of catheter damage." a catheter puncture could be caused either by advancing the needle through the partially inserted catheter or withdrawing the partially inserted catheter against the needle tip.Other remarks: the report of difficulty removing the device from the patient was confirmed through examination of the returned sample.The catheter body was crumpled and had been punctured by the needle just below the hub of the catheter.The guide wire was kinked, but not unraveled.A dhr review was performed and it did not reveal any manufacturing related issues.Based on the location of the catheter puncture and the information provided by the customer, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that the spring wire guide was difficult to remove.Gentle removal of the device was successful and resulted in a hematoma at the insertion site.

• Brand Name: ARROW RA CATH SET: 22 GA X 1-3/8"
• Type of Device: WIRE GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6523399
• MDR Text Key: 73819910
• Report Number: 9680794-2017-00078
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: RA-04122
• Device Lot Number: 14F15J0161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1