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 Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is for the third in a series of three consecutive product problems with the same patient.The first and second issues have been reported under mdr # 3006425876-2016-00359 and 3006425876-2016-00358.

Event Description

It was reported that the event occurred at the recovery room.The guidewire could be inserted without problems.After insertion of the dilator resistance was felt, dilator could not be inserted fully and the guidewire had to be removed together with the dilator.After removal, the dilator was found to be split and bent.There was no issue with the guidwire.As a result a fourth attempt was performed with success.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the dilator split and bent was confirmed.Returned was a dilator.The dilator body was slightly bent at the distal end.Under microscopic examination, the distal tip of the dilator was split and folded back in one location.There were white regions in the tip, indicating that it had been exposed to stress.The inside diameter (id) of the dilator tip could not be measured due to the damage to the tip.The instruction booklet provided with the kit describes an insertion procedure including the step to enlarge the cutaneous puncture site with the cutting edge of a scalpel prior to dilating.The customer did not report whether or not this step was performed.The device history records were reviewed with no evidence to suggest a manufacturing related issue.The dilator tip was split and folded back in one location, which is characteristic of the dilator encountering resistance during insertion.Based on the appearance of the tip and the report that it occurred during insertion, operational context caused or contributed to this event.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: 6103531
• MDR Text Key: 59974758
• Report Number: 3006425876-2016-00360
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K895417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CS-15122-F
• Device Lot Number: 71F16E0911
• Other Device ID Number: 00801902100146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• 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