MAUDE Adverse Event Report: AESCULAP AG PAS-PORT PROXIMAL ANASTOMOSIS DEVICE; ANASTOMOSIS DEVICES

Model Number FG-000001-14

Device Problem Dull, Blunt (2407)

Patient Problem Unspecified Heart Problem (4454)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a pas-port proximal anastomosis device.According to the complaint description the knob couldn´t rotate any more during surgery.The pas-port system was used for this procedure.Upon setting up of the device and positioned on aorta, the surgeon rotated the knob at the angle of 412 degrees.However,the implant was not deployed at all and a hole on aorta was made.After that, the surgeon sutured the hole and decided not to anastomosed because it is acceptable not to anastomosed for the patient.Procedure: opcab.An additional medical intervention was necessary to prevent damage to the patient.The hole was sutured.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

The reportability was reassessed and found to no longer require submission - aesculap is not the legal manufacturer of this device.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS DEVICE
• Type of Device: ANASTOMOSIS DEVICES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10586690
• MDR Text Key: 208541762
• Report Number: 9610612-2020-00589
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K091017
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Model Number: FG-000001-14
• Device Catalogue Number: FG-000001-14
• Device Lot Number: 191014F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention