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

Catalog Number 7451015ES

Device Problem Particulates (1451)

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

Event Date 03/24/2014

Event Type  malfunction  

Event Description

It was reported by a distributor from japan that particulate matter was found in the inner pouch during their receiving inspection.No patient or user injury reported.

Manufacturer Narrative

(b)(4).Baxter 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 expected to result from this issue.A follow-up report will be submitted upon receipt and evaluation of the investigation results of the sample.

Manufacturer Narrative

(b)(4).Baxter (b)(4) completed the investigation.Sample evaluation was performed.Visual and stereomicroscope inspections of the sample confirmed the presence of the particulate matter found on all four (4) samples.The samples were forwarded to baxter (b)(6) for analysis; samples 1 and 3 contained a dark color fiber identified as cotton.Samples 2 and 4 contained a single blue fiber identified as cotton as well.For samples 1, 2, and 3, the particulate matter was found in the inner pouch; however, the particulate matter in sample 4 was found between the primary and secondary container, and was not in contact with the vascular probe.Batch review was performed and baxter (b)(4) indicated that tier ii and tier iii batch records were reviewed; all specifications and requirements were met prior to release of the product.Per baxter (b)(4), this product is inspected for foreign matter at three (3) points during the manufacturing process.No manufacturing issue was found as the origin of this complaint.The source of the foreign matter cannot be determined.Capa-(b)(4) was closed and found to be effective for this issue.Baxter (b)(4) continues to monitor this complaint issue.No trend was identified.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: 3892012
• MDR Text Key: 4653492
• Report Number: 2032282-2014-00083
• 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: 06/18/2014

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 Catalogue Number: 7451015ES
• Device Lot Number: SPCE314-01A0036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 06/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2014
• 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