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	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3 - date of event was estimated as 03/20/2024, the day before the alert date.The additional prostar referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
Procedure date is estimated.It was reported that this was a vessel puncture closure using two prostar devices after an interventional procedure.Reportedly, the needle in the 10 o'clock position, misfired with both devices.Needle back down was successfully performed.A new prostar device was used 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 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 of 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.Additionally, 45 sterile unused devices were received.10 of the 45 sterile unused devices were inspected per the test plan.There was no damage noted to the sterile/unused devices.Qat testing was also performed on the 10 devices and were successfully tested.Additional information: d4 - model # added corrections: d1 - brand name updated d2a - common device name updated d3 - name updated d3 - address, city, postal code updated.

• 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: 19067133
• Report Number: 2024168-2024-04420
• Device Sequence Number: 6631276
• 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): 08/16/2024

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: 03/21/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 08/20/2024
• 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