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

Catalog Number 1012454-12

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2014

Event Type  malfunction  

Event Description

It was reported that using a right femoral artery access approach during a procedure of the ostial, proximal right coronary artery (rca) the lesion was predilatated with a 4.0 x 12 mm nc trek balloon dilatation catheter (bdc) and a 4.0 x 15 mm xience xpedition stent was deployed and it was noted that during routine post-dilatation with the 4.5 x 12 mm nc trek bdc after 3 to 4 inflations at the highest atmosphere (atm) of 16 atm, the balloon failed to fully deflate.The physician noted that the balloon could not be retracted through the 6 fr guide catheter.Both devices were removed as a system over the guide wire from the anatomy without issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.Additionally, outside the anatomy the bdc was noted to appear 'baggy' [loose]; and a technician successfully inflated and deflated the balloon without issue.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: choice pt extra support, balance middleweight, allstar; guide cath: jr4 6 fr launcher; stent: xience xpedition.Evaluation summary: the product was returned and the reported deflation difficulty could not be confirmed during return functional testing.The definitive cause of the reported deflation difficulty could not be determined.The reported guiding catheter resistance was confirmed during return testing but it was due to the flat balloon refold while the initial guiding catheter resistance was due to a partially inflated balloon.A review of the lot history record revealed no associated non-conformances that would have contributed to the reported event.A query of the complaint handling database for the reported lot did not indicate a manufacturing issue.Return analysis did not indicate a product quality deficiency.It should be noted that the nc trek instructions for use (ifu) states: with 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter.Choosing a larger guiding catheter size may minimize this.Based on the information reviewed and the return analysis, there is no indication of a product deficiency.

• 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 462
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3620724
• MDR Text Key: 18808922
• Report Number: 2024168-2014-00753
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/16/2014

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: 08/31/2016
• Device Catalogue Number: 1012454-12
• Device Lot Number: 30916G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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: 70 YR
• Patient Weight: 95