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

Catalog Number 1012453-08

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

It was reported that during the procedure to treat a lesion in the mid right coronary artery (rca) with moderate calcification and 90% stenosis, an unknown stent was implanted in the lesion and a 2.75x12 mm nc trek dilatation catheter was advanced without resistance and inflated for post-dilatation of the stent; however, the balloon ruptured at 24 atmospheres.Reportedly, the 2.75x12 mm nc trek dilatation catheter was not submerged in heparinized normal saline prior to use.The 2.75x12 mm nc trek dilatation catheter was withdrawn, resistance was felt in the lesion during withdrawal and another same sized nc trek dilatation catheter was advanced and post dilatation was completed successfully.The patient had another lesion in the proximal left circumflex with mild tortuosity, mild calcification and 85% stenosis an unknown stent was implanted and a 4.0x8 mm nc trek dilatation catheter was advanced to post-dilate but the balloon had a refold issue after the first inflation so the physician decided to change to another balloon.The balloon did not refold as expected.Reportedly, the refold issue resulted in a withdrawal issue, resistance was felt with the patient anatomy during removal of the 4.0x8 nc trek dilatation catheter; however, some force was applied and the dilatation catheter was withdrawn from the patient anatomy.A new same sized nc trek dilatation catheter was advanced and inflated; however, the same issue occurred.Reportedly, there was no deflation issue with the 4.0x8 mm nc trek dilatation catheters.When the nc trek dilatation catheter was withdrawn from the patient anatomy a non-abbott device was used to complete the procedure.

Manufacturer Narrative

(b)(4).Event description continued: there was no adverse patient effect and no clinically significant delay in the procedure.The patients final outcome was satisfactory.No additional information was provided.The additional 4.0x8 mm nc trek and the 2.75x12 mm nc trek devices referenced are being filed under separate medwatch reports.(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation.The reported poor refold was confirmed.The reported difficult to remove could not be replicated in a testing environment as it was based on operational circumstances.Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the complaint history of the reported lot did not indicate a manufacturing issue.It should be noted that the nc trek instructions for use, warnings section, states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and/or damage/separation of the catheter.Based on the information reviewed, 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: 4164098
• MDR Text Key: 4870459
• Report Number: 2024168-2014-06616
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2014

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: 03/31/2017
• Device Catalogue Number: 1012453-08
• Device Lot Number: 40408GA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2014
• Initial Date FDA Received: 10/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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: 65 YR
• Patient Weight: 73