MAUDE Adverse Event Report: ABBOTT VASCULAR INC. PROSTAR; DEVICE, HEMOSTASIS, VASCULAR

Model Number	12322-01
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an arteriotomy closure of an unspecified access site was attempted with a prostar device after a thoracic endovascular aortic repair interventional procedure.Reportedly, needle at the 10-o-clock position missed the intended opening on the device with two prostar devices.A cut-down with surgical suturing were performed to achieve hemostasis.There was no clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
The date of procedure will be estimated as (b)(6) 2024.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional prostar referenced in b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
The device was not returned for evaluation.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Factors that may contribute to the reported failure to deploy the needles may include, but are not limited to, change position of device during deployment, device orientation, over insertion of the device.A conclusive cause for the reported event could not be determined; however the treatment appears to be related to circumstances of the procedure.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Corrections: d1 ¿ brand name: updated.D2a ¿ common device name: updated.D3 ¿ name, address 1, city, postal code: updated.D9 - device available for evaluation: update from yes to no.
Event or Problem Description
The date of procedure will be estimated as (b)(6) 2024.It was reported that an arteriotomy closure of an unspecified access site was attempted with a prostar device after a thoracic endovascular aortic repair interventional procedure.Reportedly, needle position missed the intended opening on the device with two prostar devices.A cut-down with surgical suturing were performed to achieve hemostasis.There was no clinically significant delay in the procedure or therapy.No additional information was provided.

• Brand Name: PROSTAR
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19174867
• Report Number: 2024168-2024-05053
• Device Sequence Number: 7330398
• Product Code: MGB
• UDI-Device Identifier: 08717648000621
• UDI-Public: (01)08717648000621(17)250930(10)3111441
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/19/2024

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: 09/30/2025
• Device Model Number: 12322-01
• Device Catalogue Number: 12322-01
• Device Lot Number: 3111441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2023
• 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 Sex: Unknown