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

Catalog Number 7451015ES

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

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that particulate matter (pm) was observed within the inner pouch of a vascular probe.The pm was observed during incoming inspection and before patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection revealed particulate matter on the outside wall of the inner pouch.Microscopic inspection revealed that the particulate matter was a fiber.The size of the particulate matter was found to be out of specification for this product.The reported particulate matter 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.

• Brand Name: VASCULAR PROBE
• 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: 7655211
• MDR Text Key: 113009880
• Report Number: 1416980-2018-04003
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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: 7451015ES
• Device Lot Number: SP18A021264951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/26/2018
• Supplement Dates FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2018
• 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