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

Model Number 1012451-20

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.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 to post-dilate a previously implanted stent in the moderately calcified left anterior descending (lad) coronary artery.The trek balloon dilatation catheter had a contrast mix of 1/3 contrast and 2/3 saline and was inflated once to nominal pressure and upon the second inflation it was found that the balloon wasn't inflating and a rupture was suspected.The pressure was not known.There was some difficulty deflating the balloon.Negative pressure was applied for about 15 seconds and when attempting to remove the balloon there was resistance with the guiding catheter and some force was used, but all devices were removed as a unit at that point.When the balloon was removed it was found that the shaft had separated but the separated portion was in the guide catheter with the rest of the device so there was no intervention.Additionally, it was noted that the balloon was not fully deflated.Another, same size balloon was used to complete the procedure.There were no adverse patient effects and there was no delay in the procedure.No additional information was provided.

Manufacturer Narrative

H10: device code 2017- contrast incorrect.Visual and functional inspections were performed on the returned device.The reported separation was confirmed; however, the reported balloon rupture and deflation issue could not be confirmed.The reported difficulty removing the device from the guiding catheter 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 account reported that force had to be used to remove the device.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) state: 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, it is likely that the ifu deviation contributed to the reported separation.Additionally, it was reported that the contrast mix used during the procedure was 1/3 contrast and 2/3 saline.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use specify that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported balloon rupture and deflation issue.The reported difficulty removing the device appears to be related to circumstances of the procedure.The reported separation appears to be related to user error/operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12583978
• MDR Text Key: 274970800
• Report Number: 2024168-2021-08950
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1012451-20
• Device Catalogue Number: 1012451-20
• Device Lot Number: 10223G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 91 KG