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 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after the catheter was inserted, resistance was encountered when attempting to remove the guide wire.As a result, the guide wire severely kinked.A new kit was opened and used without issue.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: it was reported that resistance was encountered when attempting to remove the guide wire and the guide wire severely kinked was confirmed.One guide wire was returned.The catheter involved in the incident was not returned.The customer also provided a photograph of a curled guide wire and cs-15122-f kit inside a plastic bag.The returned guide wire had three bends / curls on the proximal 30 cm of the body.A manual tug test confirmed that both welds remain intact and the wire feels typical.The guide wire graphic specifies an outside diameter of.838/.877 mm and a length of 683 +/-4 mm.The guide wire length was confirmed to be consistent with the graphic.The outside diameter measured.854 mm, also met specifications.The instructions booklet describes suggested techniques to minimize the likelihood of guide wire damage during use.A device history record review was performed and did not reveal any manufacturing related issues.The probable cause of this issue could not be determined based on the information provided and without a complete sample.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 INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5619515
• MDR Text Key: 44013950
• Report Number: 1036844-2016-00236
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 23F15E1642
• Other Device ID Number: 00801902001139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2015
• 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