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 02/17/2021

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 to aesculap ag that a pas-port proximal anastomosis system (part # fc700su) was used during an off-pump coronary artery bypass procedure that was performed on (b)(6) 2021.According to the complainant, two (2) sites were scheduled to be anastomosed using two (2) pas-port proximal devices.The first site was anastomosed without issue.However, the second site was not able to be graft anastomosed only by aortic incision by cutter.When the surgeon checked the product, the stapler was not separate.The surgeon immediately took out the graft from pps then anastomosed with y composite to the first graft and the incision site by cutter, and then sutured by hand sewing with felt.Additional information revealed that side branches were properly treated with 5-0 sutures, no discomfort or resistance was experienced when turning the knob, and the saphenous vein graft (svg) was removed out of surgical field.The complaint device was returned to the manufacturer for evaluation.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

Manufacturing site evaluation: the complaint device was returned to the manufacturer for physical evaluation.A visual examination was performed; no abnormalities with the pas-port device or its individual components were observed.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the reported lot number; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.The investigation into the cause of the reported problem was not able to confirm a failure mode.No abnormalities with the pas-port proximal anastomosis system were identified.Although no device issue was observed, a product safety case (psc) was initiated to evaluate the risk benefit ratio.The evaluation resulted in a field safety corrective action (fsca) and a recall was initiated.

Event Description

No changes required.

• 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: 11529952
• MDR Text Key: 254947037
• Report Number: 9610612-2021-00190
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Model Number: FC700SU
• Device Catalogue Number: FC700SU
• Device Lot Number: 52627199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention