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

Model Number	1011343-40
Medical Device Problem Codes	Break (1069); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The reported loose or intermittent connection was unable to be confirmed due to the condition of the returned device; however there was a noted cracked flush port.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that during preparation the syringe was over torqued during connection to the flush port of the device resulting in the noted longitudinal crack running across the entire length of the flush port; thus resulting in the reported loose or intermittent connection.The noted device damages (kinked/separated shaft, wrinkled sheath) likely occurred due to inadvertent mishandling or during packing for return analysis.There is no indication of a product quality issue with respect to design, manufacture or labeling.
Event or Problem Description
It was reported that during preparation of a 6-8 x 40mm acculink self-expanding stent system (sess) that saline leaked out of the side of the flushing port where the syringe attaches.The syringe connection was confirmed and no cracks were observed on the sess.The sess was not used in the procedure and was replaced with another acculink sess.There was no patient involvement and no clinically significant delay reported in the procedure.Return device analysis found a break in the shaft (not in two pieces).The account reported they were not aware of the break.No additional information was provided.

• 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: 15433569
• Report Number: 2024168-2022-09787
• Device Sequence Number: 20334831
• Product Code: NIM
• UDI-Device Identifier: 08717648076374
• UDI-Public: 08717648076374
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 09/15/2022

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: 05/31/2024
• Device Model Number: 1011343-40
• Device Catalogue Number: 1011343-40
• Device Lot Number: 2060261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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