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

Model Number 22438-19

Device Problems Difficult to Insert (1316); Material Separation (1562); Material Twisted/Bent (2981)

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during prep of an emboshield nav6 embolic protection system (eps), the filter could not be loaded into the delivery catheter (dc) pod.The dc pod was noted to be crushed and separated into two pieces.The device was not used and there was no patient involvement.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to insert was unable to be confirmed due to the condition of the returned device.The reported material twisted and separation were unable to be confirmed as the delivery catheter was not returned.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 did not indicate a lot specific quality issue.As the delivery catheter was not returned, the investigation determined a conclusive cause for the reported difficulties cannot be determined.The noted damages to the retrieval catheter (kinked) and the noted damages to the bare wire (bent core, stretched coils) likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12728888
• MDR Text Key: 280082431
• Report Number: 2024168-2021-09767
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137754
• UDI-Public: 08717648137754
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 22438-19
• Device Catalogue Number: 22438-19
• Device Lot Number: 1021561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2021
• 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