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

Model Number	1400400-08
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6 medical device problem code: 2017 above rbp.The additional device referenced in b5 is filed under a separate medwatch report number.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a dissection in the right coronary.A 4.08x8mm nc trek neo balloon dilatation catheter advanced and inflated to 32 atmospheres; however, ruptured.A a 3.5x26mm graftmaster covered stent was attempted to cross; however, failed due to anatomy.When attempting to remove the device it became stuck in the anatomy and was noted to be difficult to remove.Another unspecified device was used to successfully treat the dissection.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined that the reported balloon rupture appears to be related to user error.It was reported that the balloon was inflated to 32 atmospheres and ruptured.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek neo device is 18 atm; therefore, rbp was exceeded.In this case, it is likely that overinflating the balloon resulted in the reported balloon rupture.Based on the reported information, 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19763712
• Report Number: 2024168-2024-08459
• Device Sequence Number: 15572947
• Product Code: LOX
• UDI-Device Identifier: 08717648232701
• UDI-Public: (01)08717648232701(17)260731(10)30829G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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 Expiration Date: 07/31/2026
• Device Model Number: 1400400-08
• Device Catalogue Number: 1400400-08
• Device Lot Number: 30829G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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