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

Catalog Number VASCULAR UNKNOWN

Device Problem Material Separation (1562)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: the patient entered in the hospital because of a sceptic shock 4 days before the incident.On the 4th day of hospitalization, the catheter spontaneously separated from the rest of the device at level of the blue luer hub.This separation led to hypotension / failure of infusing amines.A new long central catheter had to be inserted.Clinical consequences: the patient's hypotension was fixed and no negative consequences for the patient.

Manufacturer Narrative

Qn#(b)(4).The actual device was not returned; however the customer provided one photo for evaluation.The photo displayed a 3-lumen cvc with an arrow pointing to the distal end of the juncture hub.An image showing a box clamp assembly with the sutures was also provided.Full visual inspection could not be performed as no sample was returned for analysis.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 patient entered in the hospital because of a sceptic shock 4 days before the incident.On the 4th day of hospitalization, the catheter spontaneously separated from the rest of the device at level of the blue luer hub.This separation led to hypotension / failure of infusing amines.A new long central catheter had to be inserted.Clinical consequences: the patient's hypotension was fixed and no negative consequences for the patient.

• Brand Name: ARROW VASCULAR UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10079247
• MDR Text Key: 191707211
• Report Number: 3006425876-2020-00439
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• 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?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1