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

Model Number	12322-01
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Failure to Fire (2610)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this was an arteriotomy closure of the left common femoral artery using a prostar xl after an endovascular aneurysm repair (evar) procedure with a 10f sheath.Reportedly, the prostar xl handle was removed with only three needles coming out of the hub.It was not possible to remove one needle.After many attempts to remove the needle, it was still stuck in the guide.The suture was cut and the device removed with significant vessel damage.A proglide suture was deployed in an attempt to achieve hemostasis yet the suture did not catch the vessel.A surgical cut down was performed with surgical closure.No reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
An analysis was performed on the returned device.The failure to fire could not be confirmed due to the condition of the device.The entrapment and retraction problem are related to the procedure circumstances and cannot be replicated in a lab environment.Production record and corrective and preventative 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 patient effect of vessel damage is listed in the prostar instructions for use (eifu), as a potential adverse event of use of the device.Based on the reported information and the observations from the returned device analysis, a definitive cause for the reported issue could not be determined.It is possible the needle deflected and/or became entangled with adjoining suture causing both failure to fire and the retraction problem leading to the entrapment; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 19949142
• Report Number: 2024168-2024-09420
• Device Sequence Number: 21073446
• Product Code: MGB
• UDI-Device Identifier: 08717648000621
• UDI-Public: (01)08717648000621(17)250228(10)3041241
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/27/2024

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: 02/28/2025
• Device Model Number: 12322-01
• Device Catalogue Number: 12322-01
• Device Lot Number: 3041241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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 Age: 78 YR
• Patient Sex: Female