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

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a vascular prove had particulate matter in the inner pouch.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).One sample was returned for evaluation.The sample was visually and microscopically examined and one black fiber approximately 1.5 mm long was found in the inner pouch.The reported condition was verified.The cause could not be determined.A capa has been opened to address this 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; 2575 university ave. w; saint paul MN 55144
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5100162
• MDR Text Key: 26898935
• Report Number: 1416980-2015-37019
• 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
• Report Date: 10/09/2015

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: No Information
• Device Catalogue Number: 7151015
• Device Lot Number: SP15G201063033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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