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

Model Number	FC700SU
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with fc700su - pas-port proximal anastomosis system.According to the complaint description,the hole was punctured in the aorta but the vein was not fixed.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results visual investigation in similar cases like the present one, the investigation did not reveal any abnormalities on the pas-port device and the individual parts itself.No damages could be found which may explain the failure pattern.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Currently the product is not sold nor marketed anymore.Recall was initiated to prevent further complications.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Common Device Name: ANASTOMOSIS DEVICES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11495292
• Report Number: 9610612-2021-00194
• Device Sequence Number: 16858050
• Product Code: FZP
• UDI-Device Identifier: 04046955241026
• UDI-Public: 4046955241026
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2022
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Device Lot Number: 52632015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention