MAUDE Adverse Event Report: ABBOTT VASCULAR INC. TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012272-15
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure performed was to treat a de novo, heavily calcified, moderately tortuous right coronary artery that is 90% stenosed.During advancement of a 2.50x15mm trek balloon dilatation catheter, resistance was felt with anatomy.Once at the lesion the balloon was inflated twice to 23 atmospheres but ruptured at 12 atmospheres on the second inflation.Therefore, a 2.00x15mm mini trek balloon dilatation was advanced but met resistance with anatomy.Once at the lesion the balloon ruptured at 8 atmospheres during the first inflation.A non-abbott balloon was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.It was reported that the balloon was inflated to 23 atmospheres (atms) twice; however, it ruptured at 12 atms.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the trek rx device is 14 atm; therefore, rbp was exceeded.In this case, it was determined that it was unlikely that inflating the balloon over the rated burst pressure contributed to the rupture since it was noted that the rupture occurred at 12 atms.Based on the information received, 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 inflation, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 2017 - above rbp.The additional device referenced in b5 is filed under a separate medwatch report number.

• Brand Name: TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21609853
• Report Number: 2024168-2025-02690
• Device Sequence Number: 8867842
• Product Code: LOX
• UDI-Device Identifier: 08717648138294
• UDI-Public: (01)08717648138294(17)250930(10)21005G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 03/14/2025

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: 09/30/2025
• Device Model Number: 1012272-15
• Device Catalogue Number: 1012272-15
• Device Lot Number: 21005G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2022
• 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
• Patient Sex: Unknown