MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYTSIS NON IMP

Catalog Number CS-22122-F

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the middle of the guidewire was bent and couldn't get in.The md took out another new product and finished the procedure.

Manufacturer Narrative

(b)(4).The customer returned an opened hemodialysis kit containing a spring wire guide (swg) within its advancer tubing, catheter, dilator, ars, introducer needle, and various other components for evaluation.Visual inspection of the swg revealed one kink in its body.Microscopic examination of the swg confirmed the kink and that both welds were in place.No other defects or anomalies were observed in the other components.The kink in the swg body was measured at 453 mm from the proximal weld.The total length of the swg measured 601 mm, which is within specifications of 596-604 mm per swg graphic.The outer diameter of the swg measured 0.854 mm which is within specifications of 0.838-0.877 mm per swg graphic.The swg was inserted into the returned ars, 18 ga introducer needle, catheter, and dilator to functionally test.The swg only encountered resistance at the kink for all four components.A manual tug test confirmed that both the distal and proximal welds were intact.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions-for-use (ifu) provided with this kit warns the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire contained one kink in its body.The returned guide wire met all relevant dimensional requirements and a device history record review based on sales history did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: the middle of the guidewire was bent and couldn't get in.The md took out another new product and finished the procedure.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10001151
• MDR Text Key: 189053568
• Report Number: 3006425876-2020-00354
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-22122-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1