MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

Catalog Number	1012272-20
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the highly calcified ostium of the left anterior descending (lad) coronary artery.The 1.2x15 mm mini trek balloon dilatation catheter (bdc) was advanced with resistance noted with the anatomy and a previously implanted stent.The balloon was inflated 6 times up to 14 atmospheres (atm) in the proximal and middle portions of the lesion but ruptured at 8 atm in the ostium.Next, the 2.5x20 mm trek bdc was advanced with resistance noted with the severe calcium and a previously implanted stent.The balloon was inflated 3 times up to 14 atm in the proximal and middle portions but ruptured at 8 atm in the ostium.The 2.0x20 mm mini trek bdc was advanced with resistance noted with the anatomy and a previously implanted stent and was inflated once in the proximal/middle of the lesion.When attempting to inflate in the ostium, the balloon ruptured at 8 atm.The 3.0x20 mm trek bdc was advanced with resistance noted with the lesion and a previously implanted stent and was inflated twice in the middle and proximal portion up to 20 atm without issue.When inflated the third time in the ostium, the balloon ruptured at 9 atm.Finally, the 3.0x20 mm trek bdc was advanced with resistance noted with the anatomy and a previously implanted stent.The balloon was inflated 4 times in the middle and proximal part of the lesion up to 10 atm without issue, but at the ostium, the balloon ruptured at 8 atm.The procedure was completed with 1.25 and 1.5 burr atherectomy.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional balloon dilatation catheter (bdc) devices referenced in b5 are filed under separate medwatch report numbers.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.The investigation determined that the reported complaints appear to be related to operational context.There was no leak noted during preparation or during the first three inflations, which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that the balloon dilatation catheter (bdc) interacted with the heavily calcified anatomy and the previously implanted stent resulting in the reported difficulty advancing the device and subsequently the balloon became damaged and ruptured during the fourth inflation.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: TREK RX 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: 19092903
• Report Number: 2024168-2024-04599
• Device Sequence Number: 7819577
• Product Code: LOX
• UDI-Device Identifier: 08717648138300
• UDI-Public: (01)08717648138300(17)260228(10)30301G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 02/28/2026
• Device Catalogue Number: 1012272-20
• Device Lot Number: 30301G1
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED PREVIOUSLY IMPLANTED STENT
• Patient Sex: Male