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

Catalog Number 1012451-15

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis; however, the complaint investigation determined the reported shaft separation was potentially 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.If excessive force is required to remove the sheath and the unit is still used, it is possible to damage the unit, including stretching of the seals, which may lead to detachment of device components.Abbott vascular performed a comprehensive investigation which included device analysis for the returned devices, 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.

Event Description

It was reported that the procedure was to treat an unknown lesion.The nc trek rx 3.5 x 15 mm shaft fractured during use.The device was replaced to complete the procedure.There were no adverse patient effects or clinically significant delay reported.No additional information can be provided.

Manufacturer Narrative

(b)(4).Correction: the date received by mfr.Date was filed incorrectly on the initial medwatch report as 12/18/2017, but should have been 11/12/2017.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; 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: 7196348
• MDR Text Key: 97915535
• Report Number: 2024168-2018-00411
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 1012451-15
• Device Lot Number: 60329G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2037-2039-2017
• Patient Sequence Number: 1
• Patient Age: 52 YR