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 Problems Bent (1059); Difficult to Advance (2920)

Patient Problems Hematoma (1884); No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned at the time of this report.The product complaint form indicates that the patient developed a hematoma.Unknown if it was the result of technique during insertion.

Event Description

The customer alleges that the user was unable to advance the guidewire through the proximal end of the needle as the guidewire bent easily.

Manufacturer Narrative

(b)(4).The customer returned a radial artery catheterization device consisting of a guide wire advancer tube, a spring wire guide (swg), a catheter, and a needle.The catheter and needle appeared typical with no anomalies.There were no kinks in the swg visible inside the advancer tube; however, the swg could not be advanced through the needle.It could move back and forth a short distance.The back of the advancer tube was cut off in order to remove the guide wire for evaluation.Under microscopic examination the guide wire coils had significant damage between 1 and 2mm from the distal tip of the wire.There were also multiple locations that exhibited a displaced coil.The outside diameter (od) of the guide wire measured 0.392mm, which met specification.The length of the guide wire measured 11.6cm, which also met specification.A review of the device history records (dhr) for the catheterization device did not reveal any manufacturing related issues.Other remarks: the report of difficulty inserting the guide wire through the needle was confirmed through examination of the returned sample.The coils of the guide wire had been damaged near the distal tip, which prevented the wire from entering the needle cannula.A dhr review was performed and it did not reveal any manufacturing related issues.Based on the nature of the damage to the wire and the information reported, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that the user was unable to advance the guidewire through the proximal end of the needle as the guidewire bent easily.

• 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: 6435268
• MDR Text Key: 70871295
• Report Number: 9680794-2017-00049
• 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: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• 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