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

Catalog Number	511100150060
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rings of 1.5mm coupler would not fully attach (close).This was observe during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection was performed which identified the rings were aligned appropriately.The approximated rings appeared to have a slight gap between them.The reported condition was verified.The cause of the condition could not be determined.It is unknown if a surgical instrument was used to put pressure on the opposing rings to aid in full approximation of the coupler device.The instruction for use (ifu) states that a small hemostat should be used, prior to ejecting the joined rings, to gently squeeze the end of the opposed jaws to ensure ring approximation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: COUPLER
• Common Device Name: 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 ; 2242702068
• MDR Report Key: 13563938
• Report Number: 1416980-2022-00623
• Device Sequence Number: 14939289
• Product Code: MVR
• UDI-Device Identifier: 10844735002628
• UDI-Public: 10844735002628
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K861985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 511100150060
• Device Lot Number: SP21C241518345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown