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

Model Number FG-000001-14

Device Problem Product Quality Problem (1506)

Patient Problem Failure to Anastomose (1028)

Event Date 08/31/2020

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 report a intraoperative back flow occured.The implant was deployed without any problem and there was a back flow at that time.The surgeon could not find the blood flow.The suregeon retrieved the svg with the implant and closed the point by using a aortic punch.After that he anastomosed the svg with the aorta by hand.Type of surgery: opcab an additional medical intervention (using aortic punch/hand surturing) was necessary.Additional information was not provided nor available.The adverse event is filed under aag reference 400484884.

Manufacturer Narrative

Investigation results: to date there is no device available for investigation.Therefore a investigation of the device itself was not possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Conclusion and measures: on the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the baisis of the device history records.Based on the investigations and results of the 8d report no capa is necessary.

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: 10593738
• MDR Text Key: 208790304
• Report Number: 9610612-2020-00544
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2021
• Device Model Number: FG-000001-14
• Device Catalogue Number: FG-000001-14
• Device Lot Number: 191014G
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/12/2020; 10/13/2020
• Supplement Dates FDA Received: 10/28/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention