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

Catalog Number	22440-31
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion the superficial femoral artery (sfa) with moderate calcification.The emboshield nav 6 was positioned in the popliteal artery and used together with the atherectomy device.Upon retrieval of the filter without resistance, the physician noticed that the tip of the wire had detached and was caught in the diaphragm of the sheath thinking it was hair because the wire had already been removed.The physician pulled it out of the diaphragm of the sheath with his gloved hand/fingertips and realized that it was the tip of the wire.The sheath stayed in the anatomy.Fluoroscopy was performed to confirm nothing was left in the anatomy.It was also stated that the patient had a stent in the proximal sfa that was placed 9 months prior to the procedure.The physician bent the proximal end of the stent inward on itself with the long up and over sheath prior to the intervention/ atherectomy/ ballooning/ stenting.This invaginated stent could have damaged the tip of the barewire.There was no adverse patient effect and there was no clinically significant delay in the procedure.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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa) with moderate calcification.The emboshield nav 6 was positioned in the popliteal artery and used together with the atherectomy device.Upon retrieval of the filter without resistance, the physician noticed that the tip of the wire had detached and was caught in the diaphragm of the sheath thinking it was hair because the wire had already been removed.The physician pulled it out of the diaphragm of the sheath with his gloved hand/fingertips and realized that it was the tip of the wire.The sheath stayed in the anatomy.Fluoroscopy was performed to confirm nothing was left in the anatomy.It was also stated that the patient had a stent in the proximal sfa that was placed 9 months prior to the procedure.The physician bent the proximal end of the stent inward on itself with the long up and over sheath prior to the intervention/ atherectomy/ ballooning/ stenting.This invaginated stent could have damaged the tip of the barewire.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported tip separation 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 revealed no other complaints reported from this lot.The investigation determined that the reported material separation was likely related to procedural circumstances.Based on the reported information, it is likely that the tip of the barewire became stretched and separated due to interaction with the atherectomy device, or the previously implanted stent from a prior procedure that was in the proximal sfa.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: BAREWIRE EMBOSHIELD FILTER DELIVERY WIRE
• Common Device Name: 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: 18504191
• Report Number: 2024168-2024-00710
• Device Sequence Number: 20781728
• Product Code: NTE
• UDI-Device Identifier: 08717648137808
• UDI-Public: 08717648137808
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K141678
• 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): 03/04/2024

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: 08/31/2026
• Device Catalogue Number: 22440-31
• Device Lot Number: 3091261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7F SHEATH; 7F SHEATH; JETSTREAM ATHERECTOMY; JETSTREAM ATHERECTOMY DEVICE
• Patient Sex: Unknown