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

Model Number	12673-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bilateral suture placement in the right and left common femoral arteries (rcfa and lcfa) with four proglide devices (three in the rcfa and one in the lcfa) using the pre-close technique prior to transcatheter aortic valve replacement (tavr) interventional procedure.Reportedly, three proglide devices were placed in the rcfa; however, two of the three proglide devices failed.The tavr procedure was completed.Manual compression was applied to achieve hemostasis for 20 minutes; however, right leg and foot pulses were absent/occluded.The method used to treat the occlusion was not provided.Additionally, one proglide device was placed in the lcfa but that device also failed.The tavr procedure was completed.The method used to achieve hemostasis was not provided.There was no adverse patient effect.No additional information was provided.
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 review of the complaint history 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.A conclusive cause for the reported patient effect of serious injury/ illness/ impairment, and the relationship to the product, if any, cannot be determined.The patient effect of occlusion is listed as potential adverse event associated with use of vessel closure devices.There is no indication of a lot of specific product quality issue with respect to the design, manufacture, or labeling of the device.B3: estimated date.The additional device referenced in b5 is filed under a separate medwatch report number.

• Brand Name: PERCLOSE PROGLIDE¿
• 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: 25546756
• Report Number: 2024168-2026-02450
• Device Sequence Number: 10763116
• Product Code: MGB
• UDI-Device Identifier: 08717648013089
• UDI-Public: (01)08717648013089(17)271130(10)6010542
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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 Model Number: 12673-03
• Device Catalogue Number: 12673-03
• Device Lot Number: 6010542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2026
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Female