MAUDE Adverse Event Report: ABBOTT VASCULAR BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE; EMBOLIC PROTECTION SYSTEM

Catalog Number 22445-31

Device Problems Difficult to Remove (1528); Material Separation (1562); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Event Description

It was reported that during saphenous bypass thrombectomy procedure the barewire 315 guide wire was positioned in the peroneal artery and the emboshield nav6 filter in the tibiofibular trunk.During the forward and backward movements of the thrombectomy device, which were several, the distal end of the guide was often not visible.At the end of the procedure before capturing the filter it was noted that the movement had moved the guide wire, which in turn presented a bending like kink.When removing the filter together with the guide wire, the distal end of the wire separated and became trapped in the hemostatic valve of the introducer sheath.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was not returned for evaluation.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 revealed no indication of a lot specific product quality issue.Based on the information provided, the difficulty removing, and subsequent kink of the barewire tip appears to be due to circumstances of the procedure.It is likely that clearance between the inner diameter of the non-abbott atherectomy device and outer diameter of the barewire became reduced during use, resulting in a kink and causing difficulty to remove.The separation appears to be due to the kinked portion of the barewire interacting with the hemostatic valve during removal resulting in separation.Reportedly, the separated portion was simply withdrawn using a hemostatic forceps through the valve.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4: part/lot # updated from unk barewire to 22445-31, lot # 1111661.

Event Description

Subsequently, after the initial was filed it was noted that separated portion was simply withdrawn using a hemostatic forceps through the valve.No additional information was provided.

Manufacturer Narrative

Name1: facility name and address corrected.

• Brand Name: BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE
• Type of Device: EMBOLIC PROTECTION SYSTEM
• 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: 18156549
• MDR Text Key: 328620573
• Report Number: 2024168-2023-12808
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22445-31
• Device Lot Number: 1111661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEMOSTATIC VALVE; ROTAREX THROMBECTOMY