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

Catalog Number 22443-19

Device Problem Difficult to Remove (1528)

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

Event Date 01/19/2023

Event Type  malfunction  

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.

Event Description

It was reported that the emboshield embolic protection device was positioned over the barewire and a non-abbott peripheral atherectomy device was advanced over the barewire to perform atherectomy in the heavily calcified popliteal artery.During removal of the atherectomy device, it became stuck with the barewire, so all devices were removed as a single unit.There was no reported adverse patient effect and no clinically significant delay in the procedure.A new emboshield and jetstream were used to complete the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned product.The reported difficulty to remove was confirmed as the barewire was frozen in the non-abbott device (jetstream xc).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 similar complaints reported from this lot.The investigation determined that the reported difficulty was due to procedural related circumstances.It is likely that clearance between the inner diameter of the non-abbott atherectomy device and outer diameter of the barewire was reduced, likely due to anatomical conditions, resulting in the devices becoming frozen together during use.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: 16354868
• MDR Text Key: 309433330
• Report Number: 2024168-2023-01384
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 22443-19
• Device Lot Number: 1101861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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: BOSTON SCIENTIFIC JETSTREAM ATHERECTOMY DEVICE