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

Model Number	1012272-12
Medical Device Problem Codes	Material Rupture (1546); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid left circumflex coronary artery with mild calcification.The 2.5x12mm trek balloon dilatation catheter (bdc) was prepped per instructions for use.The bdc was advanced and resistance was noted with a non-abbott hemostasis valve.The balloon was attempted to be inflated to 12 atmospheres twice; however, the balloon did not hold pressure.The device was removed and the catheter was noted to be kinked and the balloon had a puncture.Another abbott bdc was used to continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A visual inspection and functional analysis were performed on the returned device.The reported kink was confirmed.The material rupture was not confirmed.The balloon inflated and held pressure with no anomalies noted.The resistance during advancement was not tested as it was a result of procedural circumstances.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.There were no leaks noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, resistance was noted during advancement due to interaction with the non-abbott hemostasis valve.Additionally, it was reported that the catheter was noted to have kinked while attempting to advance against resistance.It is likely that the kink in the catheter contributed to the failure to inflate as there was no leak or rupture observed on the returned unit.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20334452
• Report Number: 2024168-2024-11487
• Device Sequence Number: 18573894
• Product Code: LOX
• UDI-Device Identifier: 08717648138287
• UDI-Public: (01)08717648138287(17)250930(10)21025G1
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 11/07/2024

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: 09/30/2025
• Device Model Number: 1012272-12
• Device Catalogue Number: 1012272-12
• Device Lot Number: 21025G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WATCHDOG HEMOSTASIS VALVE (BOSTON SCIENTIFIC)
• Patient Age: 29 YR
• Patient Sex: Unknown
• Patient Weight: 85 KG