MAUDE Adverse Event Report: AESCULAP AG PAS-PORT PROXIMAL ANASTOMOSIS DEVICE; CARDIO-THORACIC SURGERY

Model Number FG-000001-14

Device Problem Defective Device (2588)

Patient Problem Patient Problem/Medical Problem (2688)

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 pas-port proximal.It was reported that the vein graft stuck in the canal when the device was activated, so the anastomosis did not take place.Graft was removed by destroying the device and could be sutured.Unfortunately, the article was disposed of by the or staff, therefore we will not receive the product for investigation.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the device was not available for investigation.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.The root cause cannot be established as there is to less information and no device available.

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: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10326288
• MDR Text Key: 200602367
• Report Number: 9610612-2020-00332
• 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,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Model Number: FG-000001-14
• Device Catalogue Number: FG-000001-14
• Device Lot Number: 191014J
• Was Device Available for Evaluation?: No
• 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