MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX; CORONARY DILATATION CATHETER

Model Number 1012455-20

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562)

Patient Problem Embolism (1829)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Exemption number (b)(4).

Event Description

It was reported that the patient presented with a heavily tortuous iliac artery with heavy calcification.The nc trek dilatation catheter advanced and dilatation was performed one time at 14 atmospheres without issues.The balloon was deflated for withdrawal.Upon retraction into the sheath, unusual resistance was met and the balloon had separated from the delivery catheter and embolized into the aorta.A snare successfully removed the separated portion.Nothing was left in the patient's anatomy.There was no adverse patient sequela and no clinically significant delay reported.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 identified no other similar incidents and/or complaints from this lot.The reported patient effect of embolism is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use as a known patient effect.It was reported that the device was used to treat the iliac artery.It should be noted that the coronary dilatation catheters (cdc), nc trek rx instructions for use states: the nc trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion and balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device; however, the reported separation, removal of foreign body and additional treatment appear to be related to operational context.A conclusive cause for the reported patient effect of embolism and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9152412
• MDR Text Key: 162634826
• Report Number: 2024168-2019-12333
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152160
• UDI-Public: 08717648152160
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 1012455-20
• Device Catalogue Number: 1012455-20
• Device Lot Number: 90422G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention