MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; PERCUTANEOUS CATHER

Catalog Number CV-15703

Device Problems Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleged that during insertion, the guide wire frayed and would not allow passage of the device.No patient harm reported.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed with no relevant findings.Complaint verification testing could not be performed as no sample was returned for analysis.A dhr review did not reveal any manufacturing related issues.The potential cause of the guide wire unraveling during insertion 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 alleged that during insertion the guide wire frayed and would not allow passage of the device.No patient harm reported.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: PERCUTANEOUS CATHER
• 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: 6210143
• MDR Text Key: 63478977
• Report Number: 9680794-2016-00247
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: CV-15703
• Device Lot Number: 14F16B0064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2016
• 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