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

Model Number FC700SU

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a pas-port proximal anastomosis system (part # fc700su) was used during an off-pump coronary artery bypass (opcab) procedure performed on (b)(6) 2021.According to the complainant, during the procedure, a pasport system was used, however, after rotating the knob, only a hole was made in the aorta and bleeding occurred.The saphenous vein graft (svg) was removed from the tip of pps bady, and then the procedure was completed using the side clamp.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Type of Device: ANASTOMOSIS DEVICES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11827452
• MDR Text Key: 264431081
• Report Number: 9610612-2021-00365
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04046955241026
• UDI-Public: 4046955241026
• Combination Product (y/n): N
• PMA/PMN Number: K202124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention