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

Model Number	12322-01
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
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.
Event or Problem Description
It was reported that this was an arteriotomy closure of the right common femoral artery using a prostar relative to an interventional procedure.Reportedly, reportedly, the needle in the 10 o'clock position, misfired.Needle back down was unsuccessful and the device was stuck in the patient.A cut down was performed to remove the stuck device and achieve hemostasis.Due to the cut down, a clinically significant delay was reported.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The failure to fire was not confirmed.Entrapment is based on case conditions and cannot be replicated in a lab environment.Testing of return sterile devices from the same lot was conducted.No abnormalities were indicated.The production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The cause of the difficulties cannot be determined.The subsequent treatment is related to the circumstances of the procedure.In this case, despite the 45° angle of the device, there may have been anatomical conditions that placed additional bend in the device to cause the misalignment; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 19067236
• Report Number: 2024168-2024-04417
• Device Sequence Number: 6593249
• 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): 08/05/2024

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?: Device Returned to Manufacturer
• 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: 08/01/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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