MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 2-LUMEN 7 FR X 16 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number AK-42702-CDC

Device Problems Kinked (1339); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was discarded by the user facility.

Event Description

The customer alleges that when the kit was opened, the guidewire was kinked and unable to use.The alleged issue was detected prior to patient use.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the spring wire guide with no evidence to suggest a manufacturing related cause.Therefore, the probable cause of a kinked spring wire guide could not be determined based upon the information provided and without a sample.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that when the kit was opened, the guidewire was kinked and unable to use.The alleged issue was detected prior to patient use.

• Brand Name: ARROW CVC KIT: 2-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6369262
• MDR Text Key: 68775035
• Report Number: 3003737899-2017-00017
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/29/2018
• Device Catalogue Number: AK-42702-CDC
• Device Lot Number: 13F16H0225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• 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