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

Catalog Number 7451015ES

Device Problem Product Quality Problem (1506)

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

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 and the returned sample was forwarded to the center for spectroscopy and imaging to baxter (b)(4) for analysis.Stereomicroscopic examination and polarized light microscopy were performed and the results are as follows: unit 1 - a single navy blue fiber, approx.1.7mm long, was found between the inner and outer pouches and was identified as cotton.Unit 2 - two black fibers, 4.3mm and 1.1mm in length, were found inside the inner pouch and identified as cotton.Unit 3 - a single blue fiber, 2.2mm in length, was found within the inner pouch and was identified as cotton.Unit 4 - a single blue fiber, 1.6mm in length, was located within the inner pouch.It was identified as cotton.Batch review was performed and no instances of scrap or rework for foreign material reported in those lots.Released product met all specifications and requirements.No trend was identified.(b)(4) has been opened to investigate these occurrences.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: 3691156
• MDR Text Key: 4244581
• Report Number: 2032282-2014-00051
• 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: 10/15/2017
• Device Catalogue Number: 7451015ES
• Device Lot Number: SPCE313-08H0002
• 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: 05/09/2014
• Initial Date FDA Received: 03/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2014
• 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: Initial
• Patient Sequence Number: 1