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

Model Number	1012276-30
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
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 the procedure was to treat the left anterior descending (lad) coronary artery and the circumflex coronary artery.Two non-abbott stents were implanted.The procedure was continued with a 3.50 x 30 mm trek balloon dilatation catheter (bdc) and a 4.0x15 mm trek bdc using the kissing balloon technique.The 4.0x15 mm trek bdc was removed with no issues.However, there was resistance felt during removal of the 3.5x30 mm trek bdc and some force was briefly applied.Once the bdc was removed it was noted that the balloon had broken off from the shaft area.Intravascular ultrasound (ivus) was performed and found that the balloon had separated and remained stuck on the previously implanted stent in the patient anatomy.A snare was attempted but was unsuccessful.The patient was transferred to icu and surgery was performed on (b)(6) 2024.The patient is stable in the intensive care unit as of 07/17/2024.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive 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.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use (ifu) states: 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.In this case, it is likely that the combination of the reported difficulty removing the device and the violation of the ifu contributed to the reported separation.The investigation determined the reported difficulty removing the device, delay to treatment/therapy, hospitalization, surgical intervention and unexpected medical intervention appear to be related to operational context.The investigation determined the reported separation appears to be related to user error/operational context.There was no report of any damage observed to the balloon dilatation catheter (bdc) prior to the procedure which may suggest that a product issue did not contribute to the reported complaint.It was reported the kissing balloon technique was attempted, which likely contributed to the reported difficulty removing the device due to interactions with other devices (previously implanted stents) as the clearances were reduced.Further manipulation, with applied force, in the attempt to remove the device as resistance was encountered likely contributed to the balloon separating.Additional treatment with a snare device was attempted to remove the separated balloon out of the patient but was unsuccessful.The patient was transferred to icu and surgery was performed.The patient had to be hospitalized.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 correction: medical device problem code 2017/excessive force added.

• Brand Name: 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: 19865115
• Report Number: 2024168-2024-09009
• Device Sequence Number: 8150024
• Product Code: LOX
• UDI-Device Identifier: 08717648138607
• UDI-Public: (01)08717648138607(17)260531(10)30605G1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• 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): 08/08/2024

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: 05/31/2026
• Device Model Number: 1012276-30
• Device Catalogue Number: 1012276-30
• Device Lot Number: 30605G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-ABBOTT PREVIOUSLY IMPLANTED STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown