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

Model Number	1012449-20
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified mid circumflex artery.An nc trek balloon was selected for post dilatation of a previously deployed stent.The nc trek was advanced, with some resistance noticed via anatomy, but was still able to cross.Once the nc trek reached the lesion, it was inflated once and contrast leakage coming from the shaft was noted.It was decided to remove the device and when pulling out- the shaft separated, with the distal part of the shaft remaining partially within the guide catheter and the proximal shaft able to be removed.Another balloon was inserted and inflated between the guide catheter and separated distal shaft of the nc trek to secure it and successfully remove it without issue.A final angiogram was performed and images were good and no issues with the patient.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported separation and kink were confirmed; however, the reported leak and inflation issue were not confirmed.Although, the reported leak and inflation issue were not confirmed during return analysis, it is likely that since the shaft separated it gave the impression of a leak/inflation issue.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances.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 incidents/complaints from this lot.The investigation determined the reported complaints and additional treatment appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified mid circumflex artery.An nc trek balloon was selected for post dilatation of a previously deployed stent.The nc trek was advanced, with some resistance noticed via anatomy, but was still able to cross.Once the nc trek reached the lesion, it was inflated once and contrast leakage coming from the shaft was noted.It was decided to remove the device and when pulling out- the shaft separated, with the distal part of the shaft remaining partially within the guide catheter and the proximal shaft able to be removed.Another balloon was inserted and inflated between the guide catheter and separated distal shaft of the nc trek to secure it and successfully remove it without issue.A final angiogram was performed and images were good and no issues with the patient.There was no adverse patient sequela and no clinically significant delay.Subsequent to the initially filed mdr report, additional information was received: [when advancing the nc trek, the shaft became kinked due to resistance with anatomy.Additionally, when inflating once, the balloon couldn't inflate fully.] 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: 15352832
• Report Number: 2024168-2022-09381
• Device Sequence Number: 20346193
• Product Code: LOX
• UDI-Device Identifier: 08717648151880
• UDI-Public: 08717648151880
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 1012449-20
• Device Catalogue Number: 1012449-20
• Device Lot Number: 20504G1
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 95 KG