MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012280-15
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	03/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device problem code 2017 - excessive force.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 a de novo lesion in the right coronary artery (rca) with 70% stenosis, moderate calcification and moderate tortuosity.The 5.0x15mm trek rx balloon dilatation catheter (bdc) had no resistance during advancement and was successfully used for post-dilatation.However, the deflated balloon could not be retrieved through the guiding catheter due to resistance.The balloon was inflated and deflated several times in attempts to get through the guiding catheter.Force was applied.The guiding catheter and the balloon were removed together but it was noted that the distal portion of the balloon was left in the aorta.A snare device was used to retrieve the separated portion.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon separation could not be replicated/confirmed in a testing environment as the balloon portion was not returned for analysis.The reported difficulty removing the device 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 similar incidents and/or complaints from this lot.It was reported that force was applied against the reported resistance and the balloon separated.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use 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 violation of the ifu contributed to the reported separation as the device separated after force was applied.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device; however, the reported separation appears to be related to user error/operational context.The reported unexpected medical intervention appears to be related to circumstances of the procedure.Possible factors that can contribute to difficult to remove/resistance with the guiding catheter post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends or procedural technique.Additionally, it should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use states: with 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter.In this case, a conclusive cause for the reported difficulty removing the device could not be determined.Additionally, force was applied against the reported resistance and the device ultimately separated.Additional treatment with a snare device was used to retrieve 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: 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: 16701723
• Report Number: 2024168-2023-03587
• Device Sequence Number: 5670907
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: 08717648138782
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 03/31/2025
• Device Model Number: 1012280-15
• Device Catalogue Number: 1012280-15
• Device Lot Number: 20425G1
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F GUIDING CATHETER - LAUNCHER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown