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

Model Number FG-000001-14

Device Problems Product Quality Problem (1506); Defective Component (2292)

Patient Problems Patient Problem/Medical Problem (2688); Unspecified Heart Problem (4454)

Event Date 06/24/2020

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 description the knob could not rotate any more during surgery.Upon setting up an positioning on the aorta the surgeon tried to rotate the knob to deploy the implant.It was stuck after the cutter was fired and doctor could not rotate the knob any more.As a result of this failure a hole was made on the aorta.The hole was sutured and decomposed the device to retrieve the svg.Another pas-port was used to complete the procedure.An additional medical intervention was necessary.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

The reportability was reassessed and found to no longer require submission - aesculap is not the legal manufacturer of this device.

Manufacturer Narrative

Visual investigation: the pas-port device is in a used condition.After the unpacking of the pas-port, it could be ascertained that heavenly deformed implant is still fixed at the implant carrier unit.It seems that the knob has been turned to its end.The three pins are correctly seated at the tracks of the cam.No unexpected deviations at the cam have been found.The tracks of the cam are not showing any damages.Furthermore, no abnormalities could be found at the seal housing.Batch history review: the device history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot number.Root cause: the investigation did not reveal any abnormalities on the pas-port device and the individual parts itself.The present situation is not comprehensible, implant still fixed at the implant carrier and does not fit to the complaint description.Unfortunately, the so called poke-through tools, which are necessary to fixate the vessel on the implant, have not been forwarded for investigation.Possibly these tools could have provided further information regarding a potential root cause.A clear conclusion can not be drawn.Measures: based on the investigations and results of the 8d report no capa is necessary.

• 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: 10344746
• MDR Text Key: 207541297
• Report Number: 9610612-2020-00316
• 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: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2021
• Device Model Number: FG-000001-14
• Device Catalogue Number: FG-000001-14
• Device Lot Number: 191014C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• 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