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

Catalog Number 1012451-15

Device Problems Inflation Problem (1310); Nonstandard Device (1420); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.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.[medwatch # 2024168-2017-02310].

Event Description

It was reported that the procedure was to treat a 95% stenosed, non-calcified lesion in the narrow mid right coronary artery (rca).When unpackaging a 3.5x15 nc trek rx balloon dilatation catheter (bdc), after flushing the lumen per the instructions for use, the protective sheath was difficult to remove; after several removal attempts and with strong force applied, the sheath was ultimately removed.The nc trek rx bdc was soaked, but air aspiration outside of the anatomy was not performed.The nc trek rx bdc was advanced to the lesion without resistance then air aspiration was performed.When attempting to inflate bdc, the balloon did not completely expand and contrast was noted under fluoroscopy to be exiting the balloon into the vessel; the balloon was reportedly broken.The bdc was withdrawn without resistance.The physician reported that the strong force required to remove the protective sheath may have caused the balloon to rupture.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.On (b)(6) 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.

Manufacturer Narrative

(b)(4).

• 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: 6465550
• MDR Text Key: 72180426
• Report Number: 2024168-2017-02883
• Device Sequence Number: 1
• Product Code: LOX
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1012451-15
• Device Lot Number: 60727G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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