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

Catalog Number	1400250-12
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: medical device problem code 2017 clarifier use after damage.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 during preparation of the 2.5x12mm nc trek neo balloon dilatation catheter (bdc), negative was pulled with the indeflator; however, more air than normal was noted to be pulled back.Despite the noted issue, the bdc was advanced to the target lesion and attempted to be inflated; however, the balloon completely failed to inflate.The procedure was completed with a non-abbott balloon.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and sem inspections/analysis were performed on the returned device.The reported leak and inflation issue were confirmed.Additionally, a balloon rupture was noted on the returned device.The electronic lot history record (elhr) 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 identified no other similar complaints from this lot.It was reported by the account that despite the noted leak during preparation, the bdc was advanced to the target lesion and attempted to be inflated.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, electronic instruction for use states: prior to use examine the device carefully for defects or damage.Examine the dilatation catheter for bends, kinks, or other damage.Do not use if the device is damaged or defective.In this case, it is unlikely that the reported violation contributed to the complaint.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the balloon failure may be attributed to mechanical damage.The longitudinal rupture was located in the distal working length, extending into the taper.Mechanical damage and tearing were documented at the rupture edges.The inner member and distal marker exhibited a diagonal crease.An exact rupture origin could not be identified.Based on the evaluation of the returned device, a potential product quality issue has been identified for the reported leak and inflation issue.A longitudinal rupture was located in the distal working length of the balloon, extending into the taper.Mechanical damage and tearing were documented at the rupture edges and the inner member and distal marker exhibited a diagonal crease which may be related to a manufacturing issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: NC TREK NEO RX
• Common Device Name: NC TREK NEO 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: 18793929
• Report Number: 2024168-2024-02475
• Device Sequence Number: 12586508
• Product Code: LOX
• UDI-Device Identifier: 08717648232404
• UDI-Public: (01)08717648232404(17)260831(10)30908G1
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 08/31/2026
• Device Catalogue Number: 1400250-12
• Device Lot Number: 30908G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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