MAUDE Adverse Event Report: COOK INC PVA FOAM EMBOLIZATION PARTICLES

Catalog Number	PVA-300
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common name: naj, agents, embolic, for treatment of uterine fibroids.Product code: naj.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that the pva foam embolization particles turned red while "turning on the vial".Part of the product(s) had been used on the patient for the tace (transcatheter arterial embolization) procedure in the liver.The cause for the red particles could not be determined with certainty, and this product problem did not result in any reported serious injuries to the patient.

• Brand Name: PVA FOAM EMBOLIZATION PARTICLES
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8167550
• Report Number: 1820334-2018-03742
• Device Sequence Number: 19269505
• Product Code: KRD
• UDI-Device Identifier: 00827002096646
• UDI-Public: (01)00827002096646(17)190101(10)5570489
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: PVA-300
• Device Lot Number: 5570489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR