MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-20
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Vascular Dissection (3160); Embolism/Embolus (4438)
Date of Event	09/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported failure to fold (winged balloon); however, the reported difficulty removing the device, separation and unexpected medical intervention appear to be related to circumstances of the procedure.The reported patient effects of embolism and vascular dissection are listed in the coronary dilatation catheters (cdc), trek rx, instructions for use as known patient effects.A conclusive cause for the reported patient effects of an embolism and vascular dissection 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.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a chronically totally occluded lesion in the proximal circumflex artery (cx).The patient presented with an acute st-elevation myocardial infarction.An unspecified guide wire was advanced and a 3.5x20mm trek rx balloon dilatation catheter (bdc) was advanced for pre-dilatation; however, when the balloon was deflated without issues the balloon did not rewrap.An attempt to remove the bdc was made, but resistance with the guide catheter was felt.The bdc was able to be pulled into the guide catheter, but the balloon separated in the guide catheter.The bdc, separated balloon, and guide catheter were removed as a unit.After removal of the devices, angiography in the left main was done and it was noted that the thrombus (occlusion) in the proximal cx had shifted to the left anterior descending coronary artery (lad) bifurcation of the cx while still also remaining in the cx.While noting the thrombus shift a dissection in the cx was also noted.The lesion was re-wired and an unspecified xience stent was deployed to successfully treat the dissection and thrombus shift.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 15574159
• Report Number: 2024168-2022-10488
• Device Sequence Number: 5959806
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 10/10/2022

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: 01/31/2025
• Device Model Number: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 20211G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown