MAUDE Adverse Event Report: AV-TEMECULA-CT EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

Catalog Number 22442-19

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).While the site was not aware of the substance and was unable to confirm the origin of the substance, the site confirmed that there were no patient effects.No additional information was provided.Evaluation summary: while there were no reported device issues, the device was inadvertently returned.Visual inspections were performed on the returned device.The returned device analysis revealed multiple types of damage on the delivery catheter which were reported to have occurred during repackaging of the device for return.The device was also received with a white sticky substance and was confirmed via chemical analysis to be a type of corrosion/rust inhibiting oil.A review of the lot history record (lhr) for the reported lot revealed no nonconforming material records (ncmr) related to this lot.A query of the complaint database for the reported original lot was performed and revealed no other related incidents.There is no indication of a product quality issue.The 1st emboshield nav 6 device is being filed under a separate manufacturing report number.

Event Description

It was reported that during the procedure to treat a mildly calcified, 60% stenosed lesion in the mildly tortuous internal carotid artery, using the provided barewire, an attempt was made to retrieve the filter of a small 190 emboshield nav6 embolic protection system (eps).However, when advancing the emboshield nav6 retrieval catheter (rc) into the artery, prior to reaching the filter, the advancement did not feel smooth (felt unusual).The emboshield nav6 was withdrawn without difficulty, before reaching the filter.Upon withdrawal, the rc was noted to be kinked.Another emboshield nav6 eps rc was used successfully advanced over the same barewire and the filter was successfully retrieved.There were no adverse patient sequelae and no occurrence of a clinically significant delay.The second nav6 embolic protection system (eps) used successfully in the procedure was inadvertently returned to the abbott vascular returned goods lab and was noted to have an unknown white sticky substance on the retrieval catheter tip.

• Brand Name: EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6291595
• MDR Text Key: 66448815
• Report Number: 2024168-2017-00824
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08717648137761
• UDI-Public: (01)08717648137761(17)181031(10)5110661
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K090665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/31/2017

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 Expiration Date: 10/31/2018
• Device Catalogue Number: 22442-19
• Device Lot Number: 5110661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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
• Patient Age: 66 YR
• Patient Weight: 63