MAUDE Adverse Event Report: ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM

Model Number	1011343-40
Medical Device Problem Codes	Break (1069); Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during unpacking of an acculink, it was noted that the hub was cracked.The device was not used and there was no patient involvement.Another stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported cracked hub was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation was unable to determine a cause for the reported cracked hub.It may be possible that inadvertent mishandling during removal from the packaging or over-torquing of the syringe on the hub during preparation caused the hub to crack; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that during unpacking of an acculink, it was noted that the hub was cracked.The device was not used and there was no patient involvement.Another stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Subsequent to the previously filed mdr reports, the account reported that the cracked hub was noted during preparation of the device as the device was unable to be flushed.
Additional Manufacturer Narrative
The investigation was unable to determine a cause for the reported cracked hub resulting in difficulty flushing.

• Brand Name: RX ACCULINK CAROTID STENT SYSTEM
• Common Device Name: CAROTID STENT
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13481924
• Report Number: 2024168-2022-01284
• Device Sequence Number: 12064707
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P040012
• 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,Followup
• Report Date (Section B): 03/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1011343-40
• Device Catalogue Number: 1011343-40
• Device Lot Number: 1090762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/18/2022; 03/22/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 02/18/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2021
• 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
• Patient Sex: Unknown