MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; ACUTE HEMODIALYSIS CATHETER PRODUCTS

Catalog Number CS-15122-F

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during insertion in the icu, difficulty was met when advancing the guide wire into the right subclavian of the overweight male patient.As a result, a new kit was opened and successfully used to complete the procedure.There was no reported d elay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4) device evaluation: the reported complaint of the guide wire became kinked during insertion was confirmed.The customer returned one guide wire.No other components were returned.Visual examination of the guide wire revealed three kinks in the wire; two at the distal end and an opened j- bend.Microscopic examination confirmed four kinks and found that three are within the j- bend and two had offset coils.Microscopic examination also confirmed that both welds were full and spherical.A manual tug test confirmed that both welds remain intact.The kinks were measured at 5 mm, 1.7, 2.1, 22.7 cm from the distal weld.The guide wire measured approximately 684mm in the total length and exhibited an outside diameter (od) measured 0.849 mm.The returned guide wire was within specification for length and od per the guide wire graphic (length: 678 - 688 mm and od: 0.838- 0.877 mm).The instructions for use describe suggested techniques to minimize the likelihood of guide wire damage during use.The device history record review was performed and did not reveal any manufacturing related issues.Since the guide wire is always inserted through another component such as an introducer needle, ars syringe, or introducer catheter and none of these components were returned, other remarks: the probable cause of this issue could not be determined.No further action will be taken.

• Brand Name: HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: ACUTE HEMODIALYSIS 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: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5948323
• MDR Text Key: 54628037
• Report Number: 3006425876-2016-00292
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K895417
• 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: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 71F16D1946
• Other Device ID Number: 00801902001139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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