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 Information (3190)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

Distributor reported: we have found foreign matter inside of the sterile pouch.No additional information provided.

Manufacturer Narrative

(b)(4).Baxter medical assessment: particulates found either on or potentially in the lumen of devices that are designed to be utilized inside blood vessels have much greater consequences for the surgical patient.As this device is intended to be used inside of blood vessels, particulate matter on or potentially inside this device has a potential to introduce the particulate directly into the vascular system.In a worst case scenario, this may lead to a compromise in blood flow through that vessel causing thrombosis or embolism.After consideration for potential harms and worst-case scenarios, an adverse health consequence is reasonably expected to result from this issue.A follow-up report will be submitted upon receipt and evaluation of the sample.

Manufacturer Narrative

(b)(4).Baxter synovis completed the investigation.Sample was available for evaluation.The returned sample was forwarded to the center for spectroscopy and imaging to baxter round lake.Visual inspection and stereomicroscopic examinations revealed the presence of a single colorless fiber, approximately 1.0mm in length, trapped in the side seal of the inner pouch.The fiber also contained black particulate matter.Micro ft-ir and polarized light microscopy identified the fiber as cotton.Visual inspection and stereomicroscopic examinations also revealed the presence of a single dark blue fiber, approximately 0.4mm in length, on the interior surface of the inner pouch.Ft-ir analysis produced a spectrum consistent with acrylic.The cause or source cannot be determined at this time.Baxter synovis further indicated that batch records were reviewed and there were no instances of scrap or rework for foreign material (fm) in these lots and released product met all specifications and requirements.(b)(4) has been opened to investigate these occurrences.This is the first reported complaint of this nature for this product lot.This complaint will be kept on record for trending purposes.

• 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: kimberly crane ; one baxter way; westlake village, CA 91362 ; 8053723182
• MDR Report Key: 3691165
• MDR Text Key: 4304245
• Report Number: 2032282-2014-00050
• Device Sequence Number: 1
• Product Code: DWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2014

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 Expiration Date: 02/19/2018
• Device Catalogue Number: 7081015ES
• Device Lot Number: SPCE313-09I0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 03/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1