MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VASCULAR PROBES; DILATOR, VESSEL, SURGICAL

Catalog Number 7151015ES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Event dates: (b)(6) 2020 and (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

Three patients underwent coronary bypass surgeries in which a vascular probe es was used.It was reported that the blood vessel wall was damaged when the device was inserted during the coronary artery bypass grafting procedures.At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.

Manufacturer Narrative

One actual device was received for evaluation.Visual inspection was performed under 30x magnification.No tip irregularities for either tip size was observed.The tips were free of sharp edges, fm, bubbles and were not bent.Coating appeared to be even, creating a smooth surface.No visual irregularities on the shaft were identified upon inspection.The reported condition was not verified.The cause of the condition could not be determined.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: VASCULAR PROBES
• Type of Device: DILATOR, VESSEL, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10837707
• MDR Text Key: 216175335
• Report Number: 1416980-2020-07105
• Device Sequence Number: 1
• Product Code: DWP
• Combination Product (y/n): Y
• PMA/PMN Number: K130896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7151015ES
• Device Lot Number: SP20C201437766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other