MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012275-12

Device Problems Entrapment of Device (1212); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Occlusion (1984)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a heavily calcified circumflex lesion.A 3.25x12mm rx trek balloon ruptured at 18 atmospheres on the second inflation.The balloon dilatation catheter (bdc) met resistance with the anatomy during retrieval and the balloon separated in the anatomy.An attempt was made to retrieve the separated balloon using an unspecified guide liner but was unsuccessful and the balloon was left in the vessel.Although the vessel was totally occluded, treatment was not done as the vessel had collaterals to the area from other vessels.Once the rx trek became stuck in the vessel, it contributed to the balance middleweight (bmw) universal ii guidewire and a non-abbott guidewire to lose distal access.The guide wire was replaced with a wiggle wire guidewire.Per the account, there was no issue with the bmw.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 from this lot.It should be noted that the trek rx and mini trek rx coronary dilatation catheter instructions for use states: balloon pressure should not exceed the rated burst pressure (rbp).Use of a pressure-monitoring device is recommended to prevent over pressurization.The reported patient effect of occlusion is listed in the trek rx and mini trek rx coronary dilatation catheter instructions for use (ifu) as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the heavily calcified anatomy resulted in compromising the balloon thus resulting in the reported material rupture.Interaction with the heavily calcified anatomy and/or manipulation of the device in attempts to remove the compromised device resulted in the reported material separation and entrapment of device.The reported difficulties possibly contributed to the reported patient effects however a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.User facility (voluntary) medwatch report number mw5091602.B3: date of event corrected from (b)(6) 2019 to (b)(6) 2019.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9432803
• MDR Text Key: 169849592
• Report Number: 2024168-2019-14250
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138492
• UDI-Public: 08717648138492
• 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,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 1012275-12
• Device Catalogue Number: 1012275-12
• Device Lot Number: 90207G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCE MIDDLEWEIGHT GUIDE WIRE; RUNTHROUGH NS GUIDE WIRE
• Patient Outcome(s): Required Intervention