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

Catalog Number 1012454-08

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 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: it should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use 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.Visual and functional inspections were performed on the returned device.The reported difficulty removing the device from the guiding catheter was confirmed; however, the reported winged (flat balloon) could not be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported winged (flat balloon); however, the reported difficulty removing the balloon dilatation catheter from the guiding catheter appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The other nc trek rx device is being filed under a separate manufacturing report number.

Event Description

It was reported that the procedure was to treat a lesion in the proximal left anterior descending (lad) coronary artery.An unspecified stent was deployed.A 4.5x8mm nc trek rx balloon dilatation catheter (bdc) was unpackaged without difficulty and prepped per the instructions for use (ifu) without issue.The 4.5x8mm nc trek rx bdc was advanced over an unspecified 0.014 guide wire, through an unspecified 6fr guide catheter, and to the deployed stent without difficultly; post-dilatation was successfully performed and the balloon was deflated without issue.During withdrawal, however, the balloon was noted to be flattened and was very difficult to retract through the guide catheter.As the physician did not want to lose guide wire positioning, force was applied to completely retract the bdc through the sheath.A 5.0x8mm nc trek rx bdc was then also unpackaged without difficulty and prepped per the ifu without issue.The 5.0x8mm nc trek rx bdc was advanced over the 0.014 guide wire, through the 6fr guide catheter, and to the deployed stent, also without difficultly; post-dilatation was successfully performed and the balloon was completely deflated without issue.During withdrawal of the bdc, however, strong resistance was felt against the guide wire and force was applied to completely retract the bdc over the guide wire.The procedure was considered completed.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• 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: 6817154
• MDR Text Key: 83645953
• Report Number: 2024168-2017-06914
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152092
• UDI-Public: 08717648152092
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/24/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 1012454-08
• Device Lot Number: 70316G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• 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: 57 YR