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

Model Number 1012451-15

Device Problems Inflation Problem (1310); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problems Ischemia (1942); Device Embedded In Tissue or Plaque (3165)

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the high diagonal left coronary artery (lca).Two non-abbott stents were implanted.Post dilatation was intended to be performed using a 3.5x15mm nc trek and there was no difficulty removing the stylet or protective sheath.During advancement, there was resistance with the anatomy.It was noted to be kinked, however, the attending physician ordered the performing physician to keep going.Under fluoroscopy, the balloon was where it should be under the stent, however, there was no indication the balloon inflated.At that point, the balloon was attempted to be retrieved without resistance but only the hypotube and short part of the catheter were removed.Another more experienced physician tried to retrieve the balloon with a snare device but was unsuccessful.At that point, there was flow but not a brisk flow.The markers were still visible so the physician put another non-abbott stent on the markers to compress the balloon to the side of the artery.The patient stayed the night and the next day parts of the catheter were retrieved by snare device but parts of the balloon embedded under the stent remained in the patient and were visible under fluoroscopy.The patient stayed the night again and was discharged the next day.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 by the account, ¿during advancement, there was resistance with the anatomy.It (¿it¿ likely refers to the balloon catheter) was noted to be kinked, however the attending physician ordered the performing physician to keep going.¿ it should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: if resistance is met during manipulation, determine the cause of the resistance before proceeding.Treatment of moderately or heavily calcified lesions is considered to be moderate risk, with an expected success rate of 60 ¿ 85%, and increases the risk of acute closure, vessel trauma, balloon burst, balloon entrapment, and associated complications.If resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.It was reported that the balloon did not inflate which likely resulted from the reported kink and subsequently upon further manipulation the shaft ultimately separated at the kinked location.The separated portion of the device remained in the patient anatomy and additional treatment with a snare was attempted but unsuccessful.At that point, there was flow but not a brisk flow.A non-abbott stent was implanted on the markers of the separated balloon to compress it to the side of the artery.The patient stayed the night and the next day parts of the catheter were retrieved by snare device, but parts of the balloon embedded under the stent remained in the patient and were visible under fluoroscopy.The patient stayed the night again and was discharged the next day.In this case, it is likely that the use of the kinked shaft contributed to the reported inflation issue and separation.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that media provided confirms what appears to be the reported balloon material in conjunction with both balloon marker components within the vessel.Additional images show the implantation of a stent at this location to enclose these components between the stent and the vessel wall.The media provided does not provide evidence of a root cause for the device failure although, per the report the following detail is provided: ¿during advancement, there was resistance with the anatomy.It (¿it¿ likely refers to the balloon catheter) was noted to be kinked, however the attending physician ordered the performing physician to keep going.¿ per the instructions-for-use (ifu) the following warnings are provided: ¿ if resistance is met during manipulation, determine the cause of the resistance before proceeding.¿ treatment of moderately or heavily calcified lesions is considered to be moderate risk, with an expected success rate of 60 ¿ 85%, and increases the risk of acute closure, vessel trauma, balloon burst, balloon entrapment, and associated complications.If resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.Per the report there was noticeable resistance during the advancement of the device which included visible damage to the catheter shaft, reported as ¿kinked¿.There is no indication, per the report, that the root cause of this resistance and subsequent device damage, was determined and / or mitigated.It appears that regardless of the ifu warnings, the damaged balloon catheter system was continued to have been advanced against this resistance, likely causing the reported failure and separation of the device components.In conclusion, the reported device failure can be connected to its usage contrary to the ifu warning, as noted previously, and is not considered to be associated with any manufacturing defects.In this case, it was reported by the account that the balloon dilatation catheter (bdc) interacted with the patient anatomy, resulting in the reported difficulty advancing the device and subsequently the reported kink.The investigation determined the reported difficulty advancing the device, kink, device embedded in tissue or plaque, removal of foreign body, unexpected medical intervention, and hospitalization appear to be related to operational context; however, the reported inflation issue and separation appear to be related to user error.A conclusive cause for the reported patient effect of ischemia and the relationship to the device, if any, cannot be determined.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
• Type of Device: 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: 13694903
• MDR Text Key: 287533067
• Report Number: 2024168-2022-02341
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012451-15
• Device Catalogue Number: 1012451-15
• Device Lot Number: 10812G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male