MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 2-LUMEN 7FR X 60CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-17752-KR

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that the tip of the swg (spring wire guide) was found bent when opening the kit.The user thought it would be unsafe to use the swg, thus a new kit was used.

Event Description

It was reported that the tip of the swg (spring wire guide) was found bent when opening the kit.The user thought it would be unsafe to use the swg, thus a new kit was used.

Manufacturer Narrative

Qn#(b)(4).The customer returned one guide wire assembly and lidstock for evaluation.The guide wire cap and straightener was not returned, indicating that the assembly was manipulated by the user.Visual analysis revealed the distal j-bend was slightly misshapen and contained offset coils.The guide wire contained slightly offset coils 3 mm from the distal tip.The total length of the guide wire measured to be 1000 mm which is within specifications of 994-1013 mm per product drawing.The outer diameter of the guide wire measured to be 0.87 mm which is within specifications of 0.86-0.90 mm per product drawing.The guide wire was advanced through a lab inventory ars/introducer needle assembly with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the customer report of a damaged guide wire was confirmed by complaint investigation of the returned sample.However, the guide wire was returned without the advancer and cap, indicating that the sample was manipulated which contradicts the reported time of discovery.The guide wire met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer description and the sample received, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC KIT: 2-LUMEN 7FR X 60CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9402562
• MDR Text Key: 179261453
• Report Number: 3006425876-2019-00996
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: ASK-17752-KR
• Device Lot Number: 71F18E1446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1