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

Model Number 1012453-12

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problems Intimal Dissection (1333); No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

Event Type  Injury  

Manufacturer Narrative

(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 during a left anterior descending (lad) coronary artery to left main (lm) intervention, after stent implantation in the lm, a 4.0x12mm nc trek balloon was inflated twice, to 20 atmospheres (atm).Negative pressure was held for 10 seconds but the balloon would not fully deflate.Resistance was met during retraction; therefore, force was used to pull the device out of the anatomy.The implanted stent became deformed and a dissection was noted in the lm.An additional stent was implanted to treat the dissection and cover the deformed stent.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deflation problem was not confirmed as the balloon was able to be deflated per specifications.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.Additionally, it was noted that the outer member and mid lap seal were stretched.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 from this lot.The reported patient effect of dissection is listed in the nc trek rx coronary dilatation catheter instructions for use (ifu) as a known patient effect of coronary procedures.It should be noted that the nc trek rx coronary dilatation catheter ifu states: balloon pressure should not exceed the rated burst pressure.Rbp for the 4.0x12mm nc trek balloon is 18atm.This deviation of the ifu does not appear to have caused or contributed to the reported device/patient issues.Additionally, ifu 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.Although resistance was noted during retraction of the device, this was due to the device being trapped within the patient¿s anatomy; therefore, the force applied during removal of the device seemed to be a reasonable clinical response.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that a sufficient time was not allowed to fully deflate the balloon resulting in the noted stretched outer member and stretched mid lap seal; thereby reducing the inflation and deflation lumen; thus, resulting in the reported deflation problem and difficult to remove.The reported difficulties possibly contributed to the reported patient effects; however, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• MDR Report Key: 10597512
• MDR Text Key: 208929148
• Report Number: 2024168-2020-08078
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152061
• UDI-Public: 08717648152061
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1012453-12
• Device Catalogue Number: 1012453-12
• Device Lot Number: 00609G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention