MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012274-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)
Date of Event	10/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with chest pain and restenosis.The procedure was to treat a heavily calcified vessel in the proximal circumflex artery and the 3.0x20mm nc trek balloon dilatation catheter (bdc) was used for pre-dilatation.Resistance was felt due to the heavily calcified lesion and the bdc was inflated once with a pressure of 20 atmospheres (atms).At this point the physician did not know that upon removal, the balloon had detached from the delivery system.Moderate force had been applied due to the nature of the calcium in the anatomy.Another stent was placed and the balloon markers were noted on check imaging.The balloon had moved to the distal circumflex.The distal circumflex artery had no blood flow for a short time, however, the patient remained stable throughout.Snare was considered but not attempted due to the small vessel.A medtronic stent was used to embed the balloon in the healthy tissue of the distal circumflex.There was no reported significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported separation was confirmed.The reported difficulty advancing and removing the device from the anatomy could not be replicated in a testing environment as it was based on operational circumstances.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 when removing the bdc which resulted in the shaft separating.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 violation of the ifu contributed to the reported separation as the device separated after force was applied.Additionally, the account reported that the balloon was over inflated to 20 atmospheres (atm).It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, ifu states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the trek rx device is 14 atm; therefore, rbp was exceeded.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded the images confirm that the balloon had been stripped off of the catheter.The images provided do not show the catheter retracted into the guide catheter.The complaint summary indicated that the vessel was heavily calcified which is presumed to have contributed to the loss of the balloon from the catheter.The images provided are poor quality thus the actual calcium is not able to be identified.The image of the balloon catheter without the balloon clearly shows the loss of the balloon material in the patient.The investigation determined the reported difficult advancing and removing the device, additional treatment and device embedded in tissue or plaque appear to be related to circumstance of the procedure.The reported shaft separation appears to be related to user error/operational context.A conclusive cause for the reported embolism 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: 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: 12782556
• Report Number: 2024168-2021-10183
• Device Sequence Number: 14982415
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: 08717648138447
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/27/2021

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: 02/29/2024
• Device Model Number: 1012274-20
• Device Catalogue Number: 1012274-20
• Device Lot Number: 10318G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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 Age: 74 YR
• Patient Sex: Male