MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK NEO¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1400400-08
Medical Device Problem Codes	Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - incorrect removal, failure to follow steps / instructions.
Event or Problem Description
It was reported that the procedure performed was to treat a circumflex artery that is 70% stenosed.A 4.00x8mm nc trek neo balloon was inflated once to 14 atmospheres and after multiple attempts to deflate the nc trek neo balloon, however unsuccessful, the partially deflated nc trek neo balloon was simply withdrawn.It was noted that the patient experienced pain during the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported deflation issue was not confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.It was reported that the contrast ration used in the procedure was 50 milliliters (mls) contrast and 40 mls heparinized saline.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instruction 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 unknown if the use of slightly more contrast than heparinized saline caused or contributed to the reported complaint.Additionally, it was reported that the balloon had to be removed inflated.It should be noted that the ifu also states: do not advance or retract the catheter unless the balloon is fully deflated under vacuum.In this case, it is unlikely that the ifu violation caused or contributed to the reported difficulty.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported deflation issue could not be determined; however, minor injury/illness/impairment appears to be related to circumstances of the procedure.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.A conclusive cause for the reported deflation issue could not be determined since the complaint could not be confirmed during return analysis.A conclusive cause for the reported patient effect of pain, and the relationship to the product, if any, cannot be determined.The reported patient effect of pain is listed in the coronary dilatation catheters (cdc), nc trek neo, ifu as a known patient effect.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 2017 - contrast incorrect.
Event or Problem Description
Subsequently after the initial report has already been filed, it is noted that the incorrect contrast ratio was mixed was used.No additional information was provided.

• Brand Name: NC TREK NEO¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21928288
• Report Number: 2024168-2025-04420
• Device Sequence Number: 9086148
• Product Code: LOX
• UDI-Device Identifier: 08717648232701
• UDI-Public: (01)08717648232701(17)270930(10)41002G1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1400400-08
• Device Catalogue Number: 1400400-08
• Device Lot Number: 41002G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown