MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 3-LUMEN 12 FR X 20 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-25123-F

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that in the icu, the catheter was inserted into the patient's right subclavian, however, difficulty was met when attempting to remove the guide wire.As a result, the catheter was removed and the dilator was passed to remove the guide wire that then came unraveled.A new kit was opened and used without issue.There was no reported delay, death, or complications to the patient as a result of this occurrence.The patient involved was a (b)(6) male who's medical history is a heart transplant.There will be no additional information to follow.

Manufacturer Narrative

(b)(4).Device evaluation: complaint verification testing could not be performed because no sample was returned for analysis.A device history record review could not be performed, because no additional information was available for the product and lot numbers.The probable cause of the guide wire unraveling during removal from the catheter could not be determined based upon the information provided and without a sample.No further actions will be taken.

Manufacturer Narrative

(b)(4).The customer returned one catheter for investigation.No guide wire was returned.Visual examination of the returned catheter revealed that the catheter appears typical but used.The blue extrusion of the catheter body is slightly discolored as a result of use.The extrusion of the distal extension line has a light indentation near the brown hub where the slide clamp has been engaged.No other defects or anomalies were observed.Dimensional inspection was performed on the distal lumen of the catheter and no dimensional defects were found.Functional testing was performed using the returned catheter with a lab inventory 0.877" guide wire.The guide wire was thread through the catheter from the distal tip as well as through the distal extension line with no resistance met.The reported complaint of resistance removing the catheter from the guide wire could not be confirmed based upon the sample received.The customer returned the catheter only.No guide wire was returned for evaluation.The returned catheter was able to thread over a lab inventory guide wire of the same size included in this kit with no resistance met.Other remarks: there were no dimensional or functional issues found with the returned catheter.However, the probable cause could not be determined based upon the information provided and without a complete sample.

• Brand Name: CVC SET: 3-LUMEN 12 FR X 20 CM
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• 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: 6039691
• MDR Text Key: 57928593
• Report Number: 3006425876-2016-00319
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-25123-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 42 YR