MAUDE Adverse Event Report: ABBOTT VASCULAR PROSTAR XL SUTURE-MEDIATED CLOSURE; VESSEL CLOSURE SUTURE

Model Number	12322-01
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an arteriotomy closure of the left common femoral artery was attempted with a prostar device after an abdominal aortic aneurysm interventional procedure using a 12f sheath.Reportedly, the knots were successfully advanced and tightened (worked as intended); however, complete hemostasis was not achieved as bleeding continued.A cutdown and manual suturing were done to achieve hemostasis.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the manufacturing records identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the treatment appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: PROSTAR XL SUTURE-MEDIATED CLOSURE
• Common Device Name: VESSEL CLOSURE SUTURE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14280393
• Report Number: 2024168-2022-04809
• Device Sequence Number: 17362035
• Product Code: MGB
• UDI-Device Identifier: 08717648000621
• UDI-Public: 08717648000621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 12322-01
• Device Catalogue Number: 12322-01
• Device Lot Number: 1102841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 105 KG