MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-15
Medical Device Problem Codes	Deflation Problem (1149); 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	01/09/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the circumflex with heavy calcification.The procedure was complex and impella protected.The contrast mix was 50:50.There was no difficulty removing the stylet or protective sheath and the device was prepared (air aspiration) outside the anatomy prior to use.The 3.5x15mm trek rx balloon dilatation catheter (bdc) was used for pre-dilatation and after a stent was deployed, the device was used again for post dilatation.The balloon was inflated three times at nominal pressure and negative was held for 10-15 seconds.However, it did not deflate at all and had to be removed inflated.The balloon catheter was pulled hard due to the resistance and separated.Everything had to be removed and the separated portion was found on the guide wire.Nothing was left in the patient.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported separation was confirmed.The reported deflation issue was not confirmed.The reported difficulty removing the device 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 since the bdc could not be fully deflated, the balloon was removed partially inflated and resistance was encountered.The balloon catheter was pulled hard due to the resistance and separated.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions 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 ifu violation contributed to the reported separation.The investigation determined the noted outer member tear, reported deflation issue and difficulty removing the device appear to be related to circumstances of the procedure.The reported separation appears to be related to user error/circumstances of the procedure.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: 16253852
• Report Number: 2024168-2023-00882
• Device Sequence Number: 14802536
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: 08717648138577
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 1012276-15
• Device Catalogue Number: 1012276-15
• Device Lot Number: 20803G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2022
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 105 KG