MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number	1012448-20
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other 3 nc trek devices referenced in b5 are filed under separate medwatch reports.
Event or Problem Description
It was reported that prior to use, during device preparation, the protective sheath of the nc trek balloon met resistance during removal.Additionally, the device was not submerged in sterile heparinized normal saline to activate the coating; however, the device was successfully used in the patient without reported issue.This occurred with 4 separate devices.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues.Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints.To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit, thus abbott vascular communicated the voluntary field action to the fda on march 17, 2017 [medwatch # 2024168-2017-02310].Corrective action has been implemented per site operating procedures.The product will continue to be trended.The abbott internal recall number is 2024168-3/14/2017-002-r.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6187880
• Report Number: 2024168-2016-09031
• Device Sequence Number: 716895
• Product Code: LOX
• UDI-Device Identifier: 08717648151835
• UDI-Public: (01)08717648151835(17)190630(10)60716G1
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1012448-20
• Device Lot Number: 60716G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 04/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1