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

Catalog Number	1012451-15
Medical Device Problem Codes	Inflation Problem (1310); Off-Label Use (1494); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) inspection/analysis were performed on the returned device.The reported inflation issue was confirmed.The returned device had a longitudinal leak between the middle of the inflation lumen and guide wire lumen, and exhibited thinned, stretched, and torn material.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.It was reported that the procedure was to treat the right common femoral artery.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) states: the nc trek rx coronary dilatation catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm ¿ 5.00 mm only).In this case, it is unknown if the ifu violation cause or contributed to the reported complaint.The investigation determined the reported complaint appears to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.E1 - facility name: (b)(6) hospital.
Event or Problem Description
It was reported that the procedure was to treat an 80% stenosed lesion in the right common femoral artery.A 3.50x15mm nc trek balloon dilatation catheter (bdc) was advanced without issue to post-dilatate an implanted stent, however, the balloon only inflated to 8 atmospheres (atm).The bdc was prepared without issue and there were no noted leaks or ruptures in the balloon.A 3.50x12mm nc trek bdc was used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.Returned device analysis found that the returned device had a longitudinal leak between the middle of the inflation lumen and guide wire lumen and exhibited thinned, stretched, and torn material.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: 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: 17725607
• Report Number: 2024168-2023-09898
• Device Sequence Number: 12513639
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K103153
• 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
• Report Date (Section B): 09/11/2023

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: 04/30/2025
• Device Catalogue Number: 1012451-15
• Device Lot Number: 20527G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• 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