MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. UNKNOWN - ARTERIAL CATHETER; CATHETER, PERCUTANEOUS

Catalog Number VASCULAR UNKNOWN

Device Problems Unable to Obtain Readings (1516); Material Deformation (2976)

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

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that the arterial catheter kinked.No measurement of arterial pressure was possible via the arterial catheter.The catheter was removed.

Event Description

The customer reports that the arterial catheter kinked.No measurement of arterial pressure was possible via the arterial catheter.The catheter was removed.

Manufacturer Narrative

(b)(6).The product code and lot number were not reported by the customer; therefore, a potential product code and lot number were selected based on a sales history review of this customer.Potential product code: sac-00820-pbx potential lot number: 71f19j0644 the customer returned one arterial catheter for evaluation.The catheter was returned with a cap secured to the proximal luer hub.Significant signs of use were detected within the extension line and interior of catheter body.Visual examination of the catheter revealed three prominent kinks in the catheter body.The kinked areas appeared creased and discolored.The catheter body contained three prominent kinks 68, 76, and 84 mm from the distal tip.The total length of the catheter body measured to be 85 mm which is within specifications of 82-86 mm per product drawing.The outer diameter of the catheter body measured to be 1.04 mm which is within specifications of 1.04-1.09 mm per product drawing.The inner diameter of the catheter tip could not be measured due to the kinks and damage.The returned catheter was flushed using a lab inventory syringe.No blockages or leaks were observed.A lab inventory guide wire was able to advance through the returned guide wire with minimal resistance.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 ifu provided with this kit warns the user, "care should be exercised that the catheter is not inadvertently kinked at the hub area when securing catheter to the patient as this may result in catheter damage, breakage and loss of arterial monitoring capabilities." the customer report of a kinked catheter was confirmed by complaint investigation of the returned sample.The catheter contained three prominent kinks in the body.Bends and kinks in the catheter body can result in interference or loss of arterial monitoring capabilities.The returned sample passed all relevant dimensional testing and a device history record review was performed based on sales history with no relevant findings.Based on the condition of the sample provided, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: UNKNOWN - ARTERIAL CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9539970
• MDR Text Key: 173537076
• Report Number: 1036844-2020-00009
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other