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

Catalog Number 7151015ES

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event occurred on an unspecified date in (b)(6) 2019.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that particulate matter (pm) was found inside the inner pouch of two (2) units of vascular probes; further described as the nature of one pm seems to be ¿a torn tyvek material¿ and the other pm seems to be ¿a broken piece of cardboard¿.This issue was identified during visual inspection prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: two (2) devices were received for evaluation.A visual inspection was performed on both returned samples.Loose particulate matter (pm) was identified inside the outer pouch of the first unit.Inspection under a microscope was conducted, and the loose pm was determined to be a piece of cardboard.Additionally, loose pm was identified on the outside of the inner pouch of the second unit.Inspection under a microscope was conducted, and the loose pm was determined to be a piece of silicone glue.The reported condition was verified.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: 9107088
• MDR Text Key: 160176785
• Report Number: 1416980-2019-05212
• 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: 11/07/2019

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?: Yes
• Device Operator: Other
• Device Catalogue Number: 7151015ES
• Device Lot Number: SP19F17-1379795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 10/21/2019
• Supplement Dates FDA Received: 11/07/2019
• 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