MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012279-15
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the left iliac artery that was heavily calcified.Using contra-lateral approach with a lima coronary guide catheter, a 4.5x15mm trek rx balloon dilation catheter was advanced to the lesion with some resistance noted.After use, during device removal against resistance, a portion of the balloon separated and remained in the leg.Intravascular ultrasound (ivus) showed blockage of flow in the artery and claudication in the knee.Another stent was advanced and implanted to embed the separated balloon material into the artery.Another 4.5x15mm trek rx balloon dilation catheter was advanced to post dilate the stent.Resistance was noted during device removal and the shaft separated outside the patient.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Medical device problem code - (b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other trek rx device referenced (b)(4) is filed under a separate medwatch report number.
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 identified no other similar incidents and/or complaints from this lot.It was reported that the procedure was to treat a lesion located in the left iliac artery that was heavily calcified.It should be noted the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use (ifu) states: the trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, balloon dilatation of a coronary artery occlusion, balloon dilatation of a stent after implantation.In this case, the use of the devices in the incorrect anatomy likely contributed to the reported complaints.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device from the guide wire; however, the reported separation appears to be related to user error/operational context.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: 14253435
• Report Number: 2024168-2022-04671
• Device Sequence Number: 14674423
• Product Code: LOX
• UDI-Device Identifier: 08717648138768
• UDI-Public: 08717648138768
• 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): 05/12/2022

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: 06/30/2023
• Device Model Number: 1012279-15
• Device Catalogue Number: 1012279-15
• Device Lot Number: 00713G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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: 64 YR
• Patient Sex: Male