MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 2-LUMEN 8FR X 20CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number DE-25802-MARL

Device Problems Kinked (1339); Split (2537); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Additional information: this product is not sold in the us.The 510k # provided is for a similar product that is sold in the us.

Event Description

It was reported that the event occurred at the anesthesia/op.In the blood vessel it was difficult to advance the guide wire and the wire kinked.The dilator split due to rough skin.No incision was performed.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the guide wire kinked was confirmed.Returned were a guide wire and a dilator.The dilator body was slightly bent at the tip.Under microscopic examination, the distal tip of the dilator was slightly pushed back in one location.There were white regions in the tip, indicating that it had been exposed to stress.There were kinks in the guide wire at 15, 25.5, and 30 cm from the bottom of the j-bend.A manual tug test confirmed that both welds were intact.The length of the guide wire measured approximately 60.1 cm.The length of the guide wire was consistent with the guide wire graphic.The outside diameter (od) of the guide wire measured 0.800 mm, which met specification of 0.788 - 0.826 mm per the guide wire graphic.The inside diameter (id) of the dilator tip could not be measured due to the damage.The proximal end of the guide wire was inserted into the distal tip of the dilator and the dilator met resistance at the first kink in the wire.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 reported that no incision was performed.The device history records were reviewed with no evidence other remarks: to suggest a manufacturing related issue.The damage to the guide wire and dilator is characteristic of encountering resistance during insertion.Based on the condition of the sample and the report that it occurred during insertion, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: CVC KIT: 2-LUMEN 8FR X 20CM
• 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: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6114200
• MDR Text Key: 60385507
• Report Number: 3006425876-2016-00363
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K900263
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Catalogue Number: DE-25802-MARL
• Device Lot Number: 71F16G0704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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