MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012280-12
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	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left main coronary artery with no tortuosity.The 5.00x12 mm trek balloon dilatation catheter (bdc) was inflated once at 14 atmospheres for 20 seconds.The contrast mix was 50/50 and there was no difficulty removing the protective sheath.At the time of deflation, there was resistance when attempting to retrieve the balloon through the guiding catheter and force was applied.The balloon was partially deflated.The physician waited 10 seconds for the balloon to deflate and the balloon separated into 3 pieces.The guiding catheter and three guide wires that were present in the anatomy were removed in order to remove the trek as a whole and all three pieces were removed.It was confirmed that no portion remained in the patient.There were no adverse patient effects.The procedure was extended for 10 minutes but there was no injury to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported separation was confirmed.The reported deflation issue and 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 had to be applied to remove the bdc as there was difficulty deflating the balloon and resistance with the guiding catheter was encountered and subsequently the device separated.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 ifu violation contributed to the reported separation.The investigation was unable to determine a conclusive cause for the reported deflation issue.However, factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.The reported difficulty removing the device appears to be related to circumstances of the procedure as it is possible that the larger profile of the 5.00 mm balloon and the reported deflation issue contributed to the resistance met with the guiding catheter during removal.Additionally, the reported separation appears to be related to user error/operational context as force had to be use to remove the device given the clinical situation.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: 13903752
• Report Number: 2024168-2022-03154
• Device Sequence Number: 14423822
• Product Code: LOX
• UDI-Device Identifier: 08717648138775
• UDI-Public: 08717648138775
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/06/2022

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: 03/31/2024
• Device Model Number: 1012280-12
• Device Catalogue Number: 1012280-12
• Device Lot Number: 10423G1
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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
• Patient Sex: Unknown