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

Catalog Number 7081015ES

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2013

Event Type  malfunction  

Event Description

Reported by distributor acp: particulate matter was found in the outer pouch.No patient or user injury reported.(b)(4) 2013: after further investigation, it was determined one of the quantity received had a particulate matter inside the inner pouch.It was identified as a single purple fiber (approx.2.5mm long) and was analyzed to be cotton.

Manufacturer Narrative

(b)(4).It was initially reported by the customer that particulate matter was found in the outer pouch which was determined to be not reportable.Baxter initial medical assessment: sterile product is not bacteriologically contaminated.The particulate matter is not in contact with the device and cannot be introduced in the vascular system.After consideration for potential harms and worst-case scenarios, no adverse health consequence is reasonably expected to result from this issue.After further investigation, particulate matter was found in the inner pouch.The case was re-assessed by the medical director.Baxter's follow-up medical assessment.Particulates found either on or potentially inside 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.Baxter synovis completed the investigation.Sample was available for evaluation.A single purple fiber (approx.2.5mm long) was found in the inner pouch and identified to be cotton.The complaint was confirmed.Batch record review was performed and all release products met specifications and no manufacturing defect was found.(b)(4) was initiated to further investigate the issue.Per synovis, source of fiber cannot be determined at this time.This case will be kept on file for trending purposes.

• Brand Name: VASCULAR PROBE
• 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: 3548795
• MDR Text Key: 4216931
• Report Number: 2032282-2014-00002
• 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
• Report Date: 10/30/2013

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: SPCE313-06F0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2013
• Initial Date Manufacturer Received: 12/17/2013
• Initial Date FDA Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• 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