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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a pas-port proximal anastomosis system (part # fc700su) was used during a off-pump coronary artery bypass (opcab) procedure performed on (b)(6) 2021.According to the complainant, the inner flange only partially deployed.Reported, after the knob was rotated, the inner flange was only partially deployed and only a hole was made in the aorta.Heart string was inserted into the hole made by pps cutter and anastomosis was performed to complete the procedure.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Additional information has not been provided or made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: the device is in a used condition.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.On the basis of the current information and knowledge, a clear conclusion cannot be drawn.Therefore, a product safety case (psc) has been initiated to evaluate the risk-benefit ratio, ref.Psc-2020-033.The evaluation resulted in a field safety corrective action (fsca), ref.Fsca-255.A recall has been initiated.Due to the aforementioned, an in-depth investigation is waived.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.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.A product recall was initiated in 2021.The devices were not marketed any longer.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Common Device Name: ANASTOMOSIS DEVICES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11576140
• Report Number: 9610612-2021-00314
• Device Sequence Number: 17257093
• Product Code: FZP
• UDI-Device Identifier: 04046955241026
• UDI-Public: 4046955241026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2021

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: 03/24/2022
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Device Lot Number: 52624646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown