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

Model Number	12322-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Production record review was performed and revealed no indication of a product quality issue.A review of the corrective and preventive actions (capa) review was not performed because a specific failure mode for this complaint was not provided.Additionally, a query of the complaint handling database for the reported lot was not performed as a similarity could not be determined.Based on the information provided, a definitive cause for the reported unspecified device issue could not be determined.The treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B3 - date of event: estimated the additional devices referenced in b5 are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that this was a closure of an unknown vessel using five prostar devices.Reportedly, an unknown issue occurred.An unknown method was used to achieve hemostasis.There was no reported adverse patient sequela and no reported 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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22048559
• Report Number: 2024168-2025-05226
• Device Sequence Number: 21080315
• Product Code: MGB
• UDI-Device Identifier: 08717648000621
• UDI-Public: (01)08717648000621(17)251231(10)4020141
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 12322-01
• Device Catalogue Number: 12322-01
• Device Lot Number: 4020141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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