MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 16CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number SA-22703-EU

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device is not sold in the us.Similar device is sold in the us.Initial triage evaluation of the sample indicates a kink in the device.

Event Description

The customer alleges that the doctor could not insert the cvc (ij right) as the guidewire was too short to complete the procedure.

Manufacturer Narrative

(b)(4).The customer returned a guide wire and an advancer.A visual exam was performed and it was observed that the guide wire was kinked 3.5cm from the bottom of the j-bend.The length and the outside diameter (od) of the guide wire were measured and were found to be within specification.A manual tug test confirmed that both welds were intact.A review of the device history records (dhr) for the guide wire did not reveal any manufacturing related issues.The customer reported that they believed the guide wire was too short to complete the procedure; however, the diameter and length of the returned guide wire met specifications for this product.During the visual examination of the sample, a kink was found 3.5cm from the distal end of the guide wire.A dhr review was performed and it did not reveal any manufacturing related issues.Based on the condition of the guide wire and the information reported, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that the doctor could not insert the cvc (ij right) as the guidewire was too short to complete the procedure.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 16CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6419107
• MDR Text Key: 70408605
• Report Number: 3006425876-2017-00107
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: SA-22703-EU
• Device Lot Number: 71F16L0941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• 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
• Patient Age: 50 YR