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); Difficult to Advance (2920)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	04/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 is filed under a separate medwatch report number.
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
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 reported patient effect of obstruction/occlusion is listed in the coronary dilatation catheters (cdc), trek rx, global, instructions for use (ifu) as a known patient effect.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, 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, it is likely that the trek rx balloon dilatation catheter interacted with the left iliac artery that was heavily calcified resulting in the reported difficulty advancing and removing of the device.Upon further manipulation of the bdc in the challenging anatomy the device ultimately separated.Therefore, the ifu violation contributed to the reported complaints.The investigation determined the reported separation, difficulty advancing and removing the device from the anatomy appears to be related to user error.The reported unexpected medical intervention appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effect of pain and obstruction/occlusion 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.

• 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: 14253437
• Report Number: 2024168-2022-04670
• Device Sequence Number: 4887622
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1012279-15
• Device Catalogue Number: 1012279-15
• Device Lot Number: 90925G1
• 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: 09/25/2019
• 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 Age: 64 YR
• Patient Sex: Male