MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. VASONOVA VASCULAR POSITIONING SYSTEM

Catalog Number VPS7220B

Device Problems Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the clinician was using the biosensor in a double lumen picc.The biosensor became stuck and the clinician used force to remove it.A blue bullseye was received and the catheter was placed successfully.It was noted that upon removal the biosensor appeared to be unraveled or broken.The customer is aware not to use excessive force to remove the stylet but did anyway.There was no patient death or complications reported.

Manufacturer Narrative

(b)(4).Device evaluation: complaint verification testing could not be performed because no sample was returned for analysis.A device history record review was performed based on sales history and did not reveal any manufacturing related issues.The probable cause of this issue could not be determined based upon the information provided and without a sample.No further action will be taken.

• Brand Name: VASONOVA VASCULAR POSITIONING SYSTEM
• Type of Device: VASCULAR POSITIONING SYSTEM
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 5619335
• MDR Text Key: 43999036
• Report Number: 3003898360-2016-00480
• 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: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPS7220B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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