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

Model Number	1012453-15
Medical Device Problem Codes	Deflation Problem (1149); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device problem code 2017 - above rbp.The device is returning for evaluation.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending artery (lad).The 4.0x15mm nc trek balloon dilatation catheter (bdc) was prepared (air aspiration) outside the anatomy prior to use and there was no difficulty removing the stylet or protective sheath.The bdc had no resistance during advancement and was inflated twice at 20 atmospheres (atms).During deflation, the balloon was slow to deflate.The balloon had to be re-inflated then deflated and was ultimately deflated.The contrast mix was per instruction for use (ifu).There was no resistance during removal.However, the catheter broke upon removal leaving the portion of the device in the lad.Another guidewire and balloon were put in alongside the device and they were able to retrieve the separated portion.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported deflation issue 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 incidents/complaints from this lot.It should be noted that the coronary dilatation catheters (cdc), nc trek, rx, global, instruction for use (ifu), states: balloon pressure should not exceed the rated burst pressure (rbp).The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported separation, removal of foreign body and unexpected medical intervention appear to be related to operational context.Possible factors that may contribute to difficulty deflating the balloon may include, but are not limited to, manufacturing, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, a conclusive cause for the reported deflation issue could not be determined.Additionally, returned device analysis noted that the material at the separation of the outer member and inner member was stretched and uneven which suggests that the separations may be related to tensile overload (material stress/fatigue).In this case, it is likely that the bdc was manipulated while the balloon was still partially inflated resulting in the noted stretching on the returned device and the reported separation.Additional treatment with a guidewire and balloon was performed by putting them in alongside the device and retrieving the separated portion.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 16485383
• Report Number: 2024168-2023-02221
• Device Sequence Number: 5848865
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: 10/31/2025
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 21125G1
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2022
• 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 Sex: Unknown