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

Model Number 1012280-15

Device Problems Deflation Problem (1149); Off-Label Use (1494); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the procedure was performed to treat a lesion in the pulmonary artery.The 5.0x15mm trek balloon dilatation catheter was pressurized twice to 6 atmospheres.The first inflation was completed without issue.On the second inflation, the balloon failed to deflate.Negative pressure was held for several minutes as the balloon never deflated with multiple aspiration attempts to deflate the balloon.There was a delay of 30 minutes due to additional images required during the attempts made to remove the device.The balloon was finally removed fully inflated using force and the guiding catheter.Although a clinically significant delay was reported, there were no reported adverse patient effects due to our device.No additional information was provided.

Manufacturer Narrative

Added device code 2017 - failure to follow steps visual and functional inspections were performed on the returned device.The reported difficulty removing the device was confirmed.The reported deflation issue 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 of the reported lot did not indicate a lot specific quality issue.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use (ifu) specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.Contrast that is more concentrated can lead to slower inflation and deflation times.In this case, it is likely that the concentrated contrast solution contributed to the reported deflation issue.Additionally, it should be noted the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use states: the 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, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, balloon dilatation of a stent after implantation.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini 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.In this case, the ifu deviation did not contribute to the reported complain, and force was required to remove the device given the clinical situation.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that the associated film media shows a fully inflated balloon consistent with the complaint description that the 5.0x15mm trek balloon failed to deflate.In the film movement can be seen that appears to be an attempt to pull the fully inflated balloon into the guiding catheter for removal from the body, once again consistent with the complaint description.While the media confirms the complaint, it does not provide a cause for the malfunction of the trek balloon catheter.The investigation determined the reported deflation issues appears to be related to user error; however, the reported difficulty removing the device 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.Na.

• Brand Name: RX TREK
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10733574
• MDR Text Key: 213006797
• Report Number: 2024168-2020-08891
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: 08717648138782
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1012280-15
• Device Catalogue Number: 1012280-15
• Device Lot Number: 00402G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1