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

Catalog Number VASCULAR UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

According to the maude report (key# (b)(4) "patient has left subclavian introducer with triple lumen slick in place.Upon assessment, it was discovered that when the sidearm/cordis was flushed, it leaked out at the attachment site to the introducer and appeared that there was a crack at this connection point.No medications were/are running through the cordis.".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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

According to the maude report (key# 10312085) "patient has left subclavian introducer with triple lumen slick in place.Upon assessment, it was discovered that when the sidearm/cordis was flushed, it leaked out at the attachment site to the introducer and appeared that there was a crack at this connection point.No medications were/are running through the cordis.".

• Brand Name: ARROW VASCULAR UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10413593
• MDR Text Key: 203132791
• Report Number: 3006425876-2020-00728
• 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: other
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNWON