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

Model Number	1012453-20
Medical Device Problem Codes	Material Separation (1562); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
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.
Event or Problem Description
It was reported that upon opening the 4.0x23 mm nc trek balloon dilatation catheter (bdc), the balloon including the markers were not on the device.The device was not used and there was no patient involvement.A new nc trek bdc was used to complete the procedure.There was a delay in the procedure; however there was no harm to the patient.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported complaint was confirmed as a balloon separation was noted on the returned device and the separated portion was not returned.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 complaint could not be determined.Return device analysis noted that the outer member was separated distal from the guidewire exit notch and the inner member was separated distal from the guidewire exit notch.The material at the separation was jagged which suggests that the separation may be related to tensile overload (material stress/fatigue).In this case, there is evidence that the balloon was initially present on the device.Possible factors that may contribute to a missing balloon may include, but not limited to, manufacturing damage, damage during sheath/stylet removal, user attempts to remove against resistance and physician applies excessive force against resistance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5: describe event or problem: updated h6: medical device problem code 1562 was corrected to 2306.
Event or Problem Description
Subsequent to the initially filed report it was stated that the device was flushed with saline which may have contained blood but the device was not advanced onto a guide wire or guiding catheter.No additional information was provided.

• Brand Name: NC TREK
• 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: 20847709
• Report Number: 2024168-2024-14287
• Device Sequence Number: 17126083
• Product Code: LOX
• UDI-Device Identifier: 08717648152085
• UDI-Public: (01)08717648152085(17)250630(10)20707G2
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K110134
• 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): 01/21/2025

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 Expiration Date: 06/30/2025
• Device Model Number: 1012453-20
• Device Catalogue Number: 1012453-20
• Device Lot Number: 20707G2
• 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: 11/15/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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