MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC FUSION 7MM-40CM UNSUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	FUSION 7MM-40CM UNSUPP PERIPHERAL GRAFT
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Event or Problem Description
The hospital reported 7mm-40cm unsupp peripheral graft reference (b)(4), lot 25153353 (delivery note: (b)(4) were received but the box was damaged.It seems that the graft is still in good shape.No patient involvement.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise #(b)(4).Updated sections: g4, g7, h2, h6, h10, h11 corrected section: h6 - health effect clinical code corrected analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period dec-2019 through nov-2020 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Device not returned: (4114/3221/67) despite request and/ or customer indicated that the device would be returned; however, no device was returned.

• Brand Name: FUSION 7MM-40CM UNSUPP PERIPHERAL GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 10979878
• Report Number: 2242352-2020-01075
• Device Sequence Number: 3019550
• Product Code: DSY
• UDI-Device Identifier: 00384409005584
• UDI-Public: 00384409005584
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K131778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: FUSION 7MM-40CM UNSUPP PERIPHERAL GRAFT
• Device Catalogue Number: VS015010470
• Device Lot Number: 25153353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown