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 10/11/2021

Event Type  malfunction  

Event Description

It was reported that the emboshield nav 6 embolic protection system (eps) filtration element could not be loaded into the delivery catheter (dc) pod.The torque device was used.Upon removal of the filtration element, it was noted that there was some wrinkling observed on the dc pod.There was no reported device use or patient involvement.There was no reported clinically significant delay in the procedure.Returned device analysis identified the delivery catheter pod was separated 13.5mm distal to the marker.The separated portion of the dc pod was not returned.Communication with the account confirmed the tip separated during preparation and was discarded.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis which identified the delivery catheter pod was separated 13.5mm distal to the marker.The reported difficult to insert was unable to be replicated in a testing environment due to the condition of the returned device.The reported material separation was able to be confirmed.The reported material twisted / bent dc pod was unable to be confirmed/tested as the dc pod 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 there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the filter was pulled into the pod too quickly and/or with excessive force resulting in the reported wrinkled dc pod; thus resulting in the reported difficult to insert.Manipulation of the device resulted in the noted device damages (stretched/offset barewire coils, multiple kink/bent barewire core) and ultimately resulted in the reported/noted material separation.The noted kink on the delivery catheter 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.

Manufacturer Narrative

The device was returned for analysis which identified the delivery catheter pod was separated 13.5mm distal to the marker.The reported difficult to insert was unable to be replicated in a testing environment due to the condition of the returned device.The reported material separation was able to be confirmed.The reported material twisted / bent dc pod was unable to be confirmed/tested as the dc pod 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 there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the filter was pulled into the pod too quickly and/or with excessive force resulting in the reported wrinkled dc pod; thus resulting in the reported difficult to insert.Manipulation of the device resulted in the noted device damages (stretched/offset barewire coils, multiple kink/bent barewire core) and ultimately resulted in the reported/noted material separation.The noted kink on the delivery catheter 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.

Event Description

It was reported that the emboshield nav 6 embolic protection system (eps) filtration element could not be loaded into the delivery catheter (dc) pod.The torque device was used.Upon removal of the filtration element, it was noted that there was some wrinkling observed on the dc pod.There was no reported device use or patient involvement.There was no reported clinically significant delay in the procedure.Returned device analysis identified the delivery catheter pod was separated 13.5mm distal to the marker.The separated portion of the dc pod was not returned.Communication with the account confirmed the tip separated during preparation and was discarded.No additional information was provided.

• 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: 13080292
• MDR Text Key: 285756785
• Report Number: 2024168-2021-12143
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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: 1051362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2021
• 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