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

Model Number 1012276-20

Device Problems Off-Label Use (1494); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.(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.

Event Description

It was reported that the procedure was to treat a left femoropopliteal bypass artery.After successful use of an armada balloon dilatation catheter, the trek rx balloon was advanced without resistance, but wrapped around a 0.014 sparta core wire and the tip of the balloon separated.The devices were removed without resistance.Snaring of the separated portion was attempted, but unsuccessful and the separated portion was left free-floating in the anatomy.A right groin angiogram was performed and showed good flow with no flow limitation to the common femoral artery in the right groin.Patient was transferred to recovery area in stable condition with no complaint of pain or discomfort.The patient will undergo ultrasound in the coming weeks to ensure that there is no limiting flow and to ensure that the patient is not experiencing any adverse effects.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported separation was 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 identified no other incidents/complaints from this lot.It should be noted that the trek rx coronary dilatation catheters (cdc), global, information for use (ifu) states: that the device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis.It is unknown if the reported ifu violation caused or contributed to the reported complaint.The investigation determined the reported complaint and patient effects appear 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.

Event Description

Subsequent to the initial 30-day medwatch report, a user facility medwatch form was received (3900420000-2019-8006).Event reported as follows: md inserting coronary dilatation catheter in the right femoral artery.The balloon got wrapped around the wire and the tip of the balloon snapped.Tried to snare the tip of the balloon however was unsuccessful.A right groin angiogram showed good flow in the external and common femoral artery with no flow limitation.Elected that this point to leave the tip of the balloon.What was the original intended procedure?: extremity angio with runoff.Other information about the patient that may have influenced the outcome of the event: there was significant stenosis and stent in the right femoral artery.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9468774
• MDR Text Key: 175023761
• Report Number: 2024168-2019-14526
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (y/n): N
• PMA/PMN Number: K103110
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• 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: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 90408G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.014 SPARTA CORE WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 88