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

Catalog Number	1400350-15
Medical Device Problem Codes	Inflation Problem (1310); 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	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the proximal left anterior descending (plad) coronary artery with mild calcification and none tortuosity.The protective sheath of the 3.50x15mm nc trek neo balloon dilatation catheter (bdc) was difficult to remove and the contrast mix was 50% saline, 50% contrast.The balloon was inflated once at 6 atmospheres for 15 seconds; however, a slow inflation was noted; therefore, before the second inflation the stopcock and the syringe were replaced.On the second inflation the balloon was inflated at 8 atmospheres for 15 seconds but the inflation problem persisted; however, the inflation was completed.After 15 seconds on negative held, the balloon was removed completely deflated.The balloon was replaced with another non-abbott balloon to complete the procedure and two non-abbott stents were implanted.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
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 performed to treat a lesion in the proximal left anterior descending (plad) coronary artery with mild calcification and none tortuosity.The protective sheath of the 3.50x15mm nc trek neo balloon dilatation catheter (bdc) was difficult to remove and the contrast mix was 50% saline, 50% contrast.The balloon was inflated once at 6 atmospheres for 15 seconds; however, a slow inflation was noted; therefore, before the second inflation the stopcock and the syringe were replaced.On the second inflation the balloon was inflated at 8 atmospheres for 15 seconds but the inflation problem persisted; however, the inflation was completed.After 15 seconds on negative held, the balloon was removed completely deflated.The balloon was replaced with another non-abbott balloon to complete the procedure and two non-abbott stents were implanted.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported inflation issue could not be confirmed during return analysis.The reported difficulty removing the protective sheath could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath and inflation issue.It was reported that resistance was noted when removing the protective sheath and the device was still used.It should be noted that the coronary dilatation catheters (cdc), nc trek neo, instruction for use states: slide the protective sheath off the balloon by grasping the catheter just proximal to the balloon (at the proximal balloon bond site), and with the other hand, grasp the protective balloon sheath and gently remove distally.If unusual resistance is felt during product mandrel and sheath removal, do not use this product, and replace with another.Follow product return procedure for the unused device.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.Possible factors that may contribute to difficulty removing the protective sheath may include, but not limited to, manufacturing, normal variation within the manufacturing process or protective sheath removal technique.Additionally, factors that may contribute to difficulty inflating may include, but are not limited to, manufacturing, poor connection with the inflation device, patient anatomical morphology and patient disease state.A conclusive cause for the reported complaint could not be determined since the complaint could not be confirmed during return analysis and the sheath component was not returned for analysis.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: 2017 device code clarifier- failure to follow steps / instructions.H6: medical device problem code 2017 added.
Event or Problem Description
Subsequent to the previously filed report, the following information was provided.It should be noted that the second inflation was at 8 atmospheres for 10 seconds, not 15 and before the second inflation the stopcock and the inflation device not the syringe were replaced as originally stated above.No additional information was provided.

• 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: 17390399
• Report Number: 2024168-2023-07966
• Device Sequence Number: 20544185
• Product Code: LOX
• UDI-Device Identifier: 08717648232633
• UDI-Public: 08717648232633
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 10/02/2023

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: 07/31/2025
• Device Catalogue Number: 1400350-15
• Device Lot Number: 20822G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 09/07/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/01/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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