VASCULAR PROBES 7151015

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for VASCULAR PROBES 7151015 manufactured by Synovis Surgical Innovations.

Event Text Entries

[142889160] 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.
Patient Sequence No: 1, Text Type: N, H10

[142889161] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-02129
• MDR Report Key: 8533779
• Date Received: 2019-04-19
• Date of Report: 2019-04-19
• Date Mfgr Received: 2019-03-31
• Date Added to Maude: 2019-04-19
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal: 60073
• Manufacturer Phone: 2242702068
• Manufacturer G1: SYNOVIS SURGICAL INNOVATIONS
• Manufacturer Street: 2575 UNIVERSITY AVE W
• Manufacturer City: SAINT PAUL MN 55114
• Manufacturer Country: US
• Manufacturer Postal Code: 55114
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: VASCULAR PROBES
• Generic Name: DILATOR, VESSEL, SURGICAL
• Product Code: DWP
• Date Received: 2019-04-19
• Model Number: NA
• Catalog Number: 7151015
• Lot Number: SP18H061318448
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SYNOVIS SURGICAL INNOVATIONS
• Manufacturer Address: SAINT PAUL MN

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-19