MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK II OTW CORONARY DILATATION CATHETER

Model Number 1012403-06A

Device Problems Unintended System Motion (1430); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 08/06/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that a 2x6mm mini trek ii balloon dilatation catheter (bdc) moved unintentionally twice, and a marker separated from the device.The marker remains in the patient anatomy, and the vein became damaged [dissection], which interfered during contrast media administration.An unspecified balloon was used to successfully complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported marker separation could not be confirmed.The reported unintended system motion (balloon slipping) could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaints.Potential factors that may contribute to unintended system motion (balloon slipping) may include, but are not limited to, patient anatomical morphology, device size selection, placement of the balloon within the lesion, or physician technique.Return analysis was unable to confirm the reported marker separation and since limited information was reported, a conclusive cause for the reported marker separation could not be determined.Additionally, it was reported that the marker remained in the patient anatomy, a dissection occurred and additional treatment with an unspecified balloon was performed to successfully complete the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: MINI TREK II OTW CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12392978
• MDR Text Key: 268971822
• Report Number: 2024168-2021-07694
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648180859
• UDI-Public: 08717648180859
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1012403-06A
• Device Catalogue Number: 1012403-06A
• Device Lot Number: 10216G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention