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

Catalog Number 7081015ES

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

Patient Problem No Patient Involvement (2645)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was particulate matter in the inner pouch of three (3) vascular probes.This was noticed before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information added to three (3) devices were returned for evaluation.A visual inspection was performed on the three samples.Loose particulate matter (pm) was present on the outside wall of the inner pouch of one unit and inside wall of the inner pouch for the other two units.The pm was inspected under the microscope and it was determined that the particle size was under 0.80 mm squared for two of the devices and over 0.80 mm squared for the third device.The particle size over 0.80 mm squared in the one sample did not meet specification.The reported condition was verified in one sample.The cause of the reported condition was 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.

• 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: 7095182
• MDR Text Key: 94224809
• Report Number: 1416980-2017-09614
• Device Sequence Number: 1
• Product Code: DWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

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
• Device Operator: Other
• Device Catalogue Number: 7081015ES
• Device Lot Number: SP17D261228263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 01/05/2018
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1