MAUDE Adverse Event Report: TELEFLEX MEDICAL VASONOVA VASCULAR POSITIONING SYSTEM (VPS)

Catalog Number VPS7220B

Device Problems Material Separation (1562); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the catheter was placed successfully with the use of vps and a blue bullseye was obtained.Upon removal, slight resistance was met when retracting the biosensor from the picc.When the biosensor was completely out, the very tip appeared to be damaged with the wire separated from the sensor but remained intact.There was no patient death or complications reported.

Manufacturer Narrative

(b)(4).It was reported the catheter was placed successfully with the use of vps and a blue bullseye was obtained.Upon removal, slight resistance was met when retracting the biosensor from the picc.When the biosensor was completely out, the very tip appeared to be damaged with the wire separated from the sensor but remained intact.The issue was confirmed.One vps biosensor stylet was returned.Visual examination at 20x magnification revealed that the transducer was missing from the end of the stylet.It appears that the transducer had been properly attached and was separated by excessive force.The stylet graphic specifies the outside diameter of the transducer encapsulation at.0185 /.0195 inches.No measurement could be made because of the condition of the returned stylet.The instruction booklet provided with the bedside kit, states that arrow vps stylets are designed to be used with catheters with a minimum inner lumen diameter of.021 inches.It was reported that the vps stylet was being used with a double-lumen bioflo picc.Information on the angiodynamics directions for use indicate that their bioflo picc catheters have a maximum other remarks: guidewire compatibility of.018 inches.It appears that the bioflo catheter used in the procedure may not be suitable for use with a vps stylet.A device history record review was performed on the stylet and did not reveal any manufacturing related issues.Use error caused or contributed to this event.A customer in-service has been initiated for this issue.

• Brand Name: VASONOVA VASCULAR POSITIONING SYSTEM (VPS)
• Type of Device: VASCULAR POSITIONING SYSTEM
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 6043483
• MDR Text Key: 57980594
• Report Number: 3003898360-2016-00988
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: VPS7220B
• Device Lot Number: 73E1600549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1