MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC FUSION BIOLINE 7MM-80CM SUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number FUSION BIOLINE 7MM-80CM SUPP PERIPHERAL GRAFT

Device Problem Material Separation (1562)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during a procedure, fusion bioline 7mm-80cm supp peripheral graft layers separated.It did not break and fall in the patient.A replacement device was used to complete the procedure.Patient went home the next day.

Manufacturer Narrative

Trackwise (b)(4) updated section: b4, e3, g4, g7, h2, h3, h6, h10, h11 corrected section: d4- udi#- corrected to unk the device was returned to the factory on 08/11/2021.An engineer evaluation was conducted on 09/15/2023 with the following results, see attached engineer evaluation: "the device, vs01503087b0 ¿ fusion bioline 7mm-80cm supp peripheral graft, was visually evaluated by the subject matter experts (smes), which includes a production supervisor and a manufacturing engineer.The evaluation determined that there was no material separation observed along the length of the graft.However, material separation was observed on the right side of the graft, specifically in areas where the graft had been cut at an oblique angle (see figure 1) and where the external support coil had been removed (see figure 2) by the end user.Therefore, the reported failure - material separation in complaint one track (b)(4) was confirmed.The lot # 25154077 history record review was completed.There was 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 batch manufacturing process and the reported failure.

Event Description

N/a.

• Brand Name: FUSION BIOLINE 7MM-80CM SUPP PERIPHERAL GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 12363414
• MDR Text Key: 268046716
• Report Number: 2242352-2021-00695
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K131778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: FUSION BIOLINE 7MM-80CM SUPP PERIPHERAL GRAFT
• Device Catalogue Number: VS01503087B0
• Device Lot Number: 25154077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male