MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS VASCULAR PROBES; DILATOR, VESSEL, SURGICAL

Catalog Number 7151015

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

One single-use device was received for evaluation.A visual inspection was performed and loose particulate matter (pm) was observed on the outside of the inner pouch.Microscopic inspection was performed and the loose pm was determined to be a piece of the suture line.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This report summarizes 1 malfunction events.It was reported that particulate matter (pm) was observed within the inner pouch of a vascular probe.The pm was discovered during incoming inspection and prior to patient use.There was no patient involvement.No additional information is available.

• Brand Name: VASCULAR PROBES
• Type of Device: DILATOR, VESSEL, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; saint paul MN
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8533779
• MDR Text Key: 142889160
• Report Number: 1416980-2019-02129
• Device Sequence Number: 1
• Product Code: DWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 04/19/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: 7151015
• Device Lot Number: SP18H061318448
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/19/2019
• Type of Device Usage: N
• Patient Sequence Number: 1