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

Catalog Number	1012451-12
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Tachycardia (2095); Ventricular Fibrillation (2130)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 70% stenosed, de novo lesion in the left anterior descending (lad) artery.During the procedure, a 3.5x12mm nc trek balloon dilatation catheter (bdc) was advanced for post-dilatation.Upon inflation of the balloon, there was no balloon rupture or re-flow, however, air and contrast were leaking from the tip of the balloon catheter, into the coronary artery.The patient experienced ventricular tachycardia (vt) and ventricular fibrillation (vf), resulting in required cardiopulmonary resuscitation (cpr).At the end of the procedure, the patient was stable.There was no adverse patient sequela.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.
Additional Manufacturer Narrative
The device was not returned for analysis.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 similar incidents from this lot.In this case, because the device is unavailable for analysis, a conclusive cause for the reported leak/splash cannot be established.Factors that may contribute to a leak / splash during use include, but are not limited to, damage incurred during manufacturing, damage incurred during processing of the balloon material, inflation technique, interactions with other devices, or lesion calcification.Additionally, the reported patient effects and treatment appear to be related to the operational context of the procedure.The reported patient effects of ventricular fibrillation and tachycardia/arrythmia are listed in the nc trek instruction for use (ifu) as a known patient effects of coronary procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.A cine was received and reviewed by an abbott clinical specialist.The reviewer concluded that ¿a 70% occluded, heavily calcified, and moderately tortuous lad was treated with a nc trek balloon dilatation catheter (bdc).The report states that this lesion is de novo lesion and has not been treated before this procedure.The balloon was advanced without issue and inflated to an unknown pressure and length of time, where no rupture was noted on angiogram.However, it appeared that they did see air and contrast leaking from the tip of the bdc into the lad.Patient went into an arrhythmia resulting in cardiopulmonary resuscitation (cpr), where the patient resulted stable post procedure.The media associated with this incident is difficult to depict exactly where the fluid is coming from yet appears that there is fluid dripping from somewhere on the bdc.I am unaware of if the product was prepped and operated per ifu, as well as the atmospheric pressure the bdc was taken to.With the lesion being heavily calcified and 70% stenosed with moderate tortuosity, we do not know if the other treatment to treat the compliance of the anatomy (since it was heavily calcified) were performed.This leads me to not be able to provide a probable cause for the event.Additional information (case specifics and/or angiographic media of the actual procedure) may impact this conclusion, if provided.D9, h3: device returning updated from no to yes.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported leak/splash was confirmed as a tear on the inner member.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 similar incidents from this lot.The investigation determined the reported leak/splash, in addition to, the reported patient effects and treatment appear to be related to the operational context of the procedure.Analysis of the returned device noted a tear on the inner member, confirming the reported leak.Imaging was performed and noted the tear protruded outward in the proximal direction.This type of damage is consistent with interaction between the balloon catheter and guide wire.It is possible that when the balloon catheter was being loaded onto the guide wire, the wire inadvertently punctured the balloon catheter¿s inner member, resulting in the noted tear.Additionally, the noted bunched balloon, kinked inner/outer member, and stretched guide wire exit notch are consistent with manipulation against resistance.The reported patient effects of ventricular fibrillation and tachycardia/arrythmia are listed in the hi-torque guide wires instruction for use as a known patient effects of coronary procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.A cine was received and reviewed by an abbott clinical specialist.The reviewer concluded that "a 70% occluded, heavily calcified, and moderately tortuous lad was treated with a nc trek balloon dilatation catheter (bdc).The report states that this lesion is de novo lesion and has not been treated before this procedure.The balloon was advanced without issue and inflated to an unknown pressure and length of time, where no rupture was noted on angiogram.However, it appeared that they did see air and contrast leaking from the tip of the bdc into the lad.Patient went into an arrhythmia resulting in cardiopulmonary resuscitation (cpr), where the patient resulted stable post procedure.The media associated with this incident report is difficult to depict exactly where the fluid is coming from yet appears that there is fluid dripping from somewhere on the bdc.I am unaware of if the product was prepped and operated per ifu, as well as the atmospheric pressure the bdc was taken to.With the lesion being heavily calcified and 70% stenosed with moderate tortuosity, we do not know if the other treatment to treat the compliance of the anatomy (since it was heavily calcified) were performed.This leads me to not be able to provide a probable cause for the event.Additional information (case specifics and/or angiographic media of the actual procedure) may impact this conclusion, if provided."e1: phone number updated from +011(091)1204173000 to +011(091)9818402779.H6: type of investigation code 4114 removed.H6: investigation conclusions code 4315 removed.

• Brand Name: NC TREK RX 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: 17502259
• Report Number: 2024168-2023-08645
• Device Sequence Number: 2442905
• Product Code: LOX
• UDI-Device Identifier: 08717648151972
• UDI-Public: 08717648151972
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup,Followup
• Report Date (Section B): 02/08/2024

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: 11/30/2025
• Device Catalogue Number: 1012451-12
• Device Lot Number: 21212G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023; 01/31/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 12/05/2023; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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