MAUDE Adverse Event Report: ABBOTT VASCULAR EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Model Number 22438-19

Device Problems Device Difficult to Setup or Prepare (1487); Product Quality Problem (1506); Difficult to Remove (1528); Component Missing (2306); Difficult to Advance (2920)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

It was reported that during device preparation, the emboshield nav6 embolic protection system (eps) was difficult to load into the delivery catheter.During the popliteal atherectomy intervention, resistance was noted with the sheath, but the eps was positioned in the vessel as desired.Additionally, the iliac artery was very tortuous.The non-abbott atherectomy system was advanced over the bare wire, but at some point in the procedure became stuck on the bare wire.An attempt was made to remove everything through the sheath, but the filter was stuck.The sheath, wire, and filter were pulled out as a single unit over a buddy wire.After removal, it was noted that there was 3 inches of black catheter stuck on the filter wire.There were no markers on the nav6 and it could not be seen while using the atherectomy system.A gap was noted in the delivery catheter where the wire was exposed mid delivery catheter.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual analysis was performed on the returned product.The reported difficulty to prepare, difficult to advance, and difficult to remove were not confirmed due to the condition of the returned unit.The reported missing markers was not confirmed as all the markers were present on the returned divide.The product quality problem was not 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 similar complaints reported from this lot.The investigation determined that the reported difficulties were likely due to procedural circumstances.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 resistance and the devices becoming stuck together causing difficulty to remove and resulting in damage/separation to the delivery catheter shaft and the barewire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• 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: 16364434
• MDR Text Key: 309581692
• Report Number: 2024168-2023-01445
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 1121661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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: JETSTREAM
• Patient Age: 79 YR
• Patient Sex: Male