MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; DEVICE, ANASTOMOTIC, MICROVASCULAR

Catalog Number ASKU

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

This event occurred during the unspecified date (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified vascular coupler was not working properly.It was further reported that the coupler did not fire correctly, further specified as the pins were misaligned which resulted in the vessel not correctly secured.This was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: upon follow up it was reported that the vein was sutured with 8/0 ethilon to anastomose.The patient was in surgery for a longer period of time due to the reported event (no further details).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: the sample was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: DEVICE, ANASTOMOTIC, MICROVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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: 9922546
• MDR Text Key: 186389749
• Report Number: 1416980-2020-01945
• Device Sequence Number: 1
• Product Code: MVR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 04/09/2020; 05/06/2020
• Supplement Dates FDA Received: 04/30/2020; 05/14/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention