MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012274-30
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The investigation determined the reported difficulty removing the device, separations, additional treatment, and foreign body in patient appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.User facility medwatch form mw5106318.
Event or Problem Description
User facility medwatch report (mw5106318) received stating: when the device was being removed from the patient, it became stuck to an area of calcium in the patient's vessel.Ultimately dislodging the balloon shaft becoming retained.Additionally, it was reported that the 3.00 x 30mm trek balloon dilatation catheter (bdc) was advanced without resistance to the moderately calcified lesion in the profunda artery.The balloon was inflated twice and deflated without issue.During removal, resistance was noted due to calcification in the vessel and the distal shaft, including the balloon separated.Snaring was performed in an attempt to remove the separated portion of the device, but it was not successful, so a bare metal stent was advanced and implanted to secure the separated portion.There was no adverse patient sequela or a clinically significant delay in 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: 13573539
• Report Number: 2024168-2022-01828
• Device Sequence Number: 5680934
• Product Code: LOX
• UDI-Device Identifier: 08717648138461
• UDI-Public: 08717648138461
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/21/2022

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 Model Number: 1012274-30
• Device Catalogue Number: 1012274-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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