MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00820

Device Problems Material Frayed (1262); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the installation was performed with ultrasound vision, without problems on the first attempt.When trying to withdraw the guide through the radial catheter, it was stuck and, to be able to withdraw it, they had to remove the catheter at the same time.The customer reports a frayed device.To make sure that no segment of the guide was left inside the artery, they performed an arterial ultrasound, ruling out the presence of traces of the guidewire inside the vascular access.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: the installation was performed with ultrasound vision, without problems on the first attempt.When trying to withdraw the guide through the radial catheter, it was stuck and, to be able to withdraw it, they had to remove the catheter at the same time.The customer reports a frayed device.To make sure that no segment of the guide was left inside the artery, they performed an arterial ultrasound, ruling out the presence of traces of the guidewire inside the vascular access.

• Brand Name: ARROW ARTERIAL CATH SET: 20GA X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7264609
• MDR Text Key: 99989929
• Report Number: 3006425876-2018-00102
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K093050
• 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: 01/30/2018

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: 03/15/2022
• Device Catalogue Number: SAC-00820
• Device Lot Number: 71F17C1254
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/12/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 03/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR