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

Model Number	1400350-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
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.The additional device referenced in b5 & d10 is filed under separate medwatch report number.H6 - adverse event problem - medical device problem - 2017 improper or incorrect procedure or method /failure to follow steps / instructions h6 - adverse event problem - medical device problem - 2017 improper or incorrect procedure or method/ incorrect removal.
Event or Problem Description
It was reported that the procedure was to treat lesions in the left anterior descending (lad) and left main (lm) arteries.After rotablation, the 3.5x20mm nc trek neo balloon dilatation catheter (bdc) was advanced on a hi-torque bmw universal 190cm guide wire (gw).The bdc was used in the procedure; however, when attempting to deflate the balloon for 2-3 seconds, the balloon would not fully deflate.An attempt was made to remove the bdc from the gw; however, the device could not be removed from each other and resistance was noted between the devices.After, several attempts the physician was able to removed the partially deflated balloon with the gw and 7 fr guide catheter (gc) as as a single unit.The procedure was continued with another nc trek neo bdc.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that the hi-torque bmw universal 190cm guide wire (gw) separated at the hypotube during the difficulty removing the 3.5 x 20mm nc trek neo balloon dilatation catheter (bdc) from the gw.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported deflation issue and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.A pinhole balloon rupture was noted on the returned device.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.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported deflation issue, difficulty removing the device and the noted balloon pinhole rupture could not be determined.In this case, it is unlikely that the reported instructions for use (ifu) violation of removing the device inflated contributed to the reported complaint; however, it is unknown if the violation of insufficient time allowed for deflation caused or contributed to the reported complaint given the clinical situation and the limited information provided on the noted balloon rupture on the returned device.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, insufficient deflation time, or damage to the guide wire, balloon, and/or inflation lumen.Return device analysis noted a pinhole balloon rupture on the returned device.In this case, it is possible that the noted balloon rupture contributed to the reported deflation issue; however, since limited information on the balloon rupture was provided, a conclusive cause cannot be determined.Possible factors that may contribute to resistance between the balloon catheter and the guide wire may include, but are not limited to, device placement technique, introducer sheath support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, or damage to the distal shaft of the catheter.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 22910170
• Report Number: 2024168-2025-09177
• Device Sequence Number: 13066725
• Product Code: LOX
• UDI-Device Identifier: 08717648232640
• UDI-Public: (01)08717648232640(17)280430(10)50505G1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/03/2025

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: 1400350-20
• Device Catalogue Number: 1400350-20
• Device Lot Number: 50505G1
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7-FR. GUIDE CATHETER.; HI-TORQUE BMW UNIVERSAL 190CM GUIDE WIRE.
• Patient Sex: Unknown