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

Model Number	1012272-12
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
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.Based on the information provided, a definitive cause for the reported complaints could not be determined.Possible factors that may contribute to difficulty removing the protective sheath may include, but not limited to, manufacturing, normal variation within the manufacturing process or protective sheath removal technique.Possible factors that may contribute to difficulty inflating and deflating the balloon include, but are not limited to, manufacturing, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.A conclusive cause for the reported complaint could not be determined since the device or component were not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9 correction: device available for evaluation: updated from yes to no.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem codemedical device problem code 2017 - failure to follow steps.
Event or Problem Description
It was reported that the procedure was to treat a de novo circumflex artery lesion.During preparation of the 2.50x12 mm trek rx balloon dilatation catheter (bdc), difficulty was noted when removing the protective sheath.The bdc was prepped and advanced for pre-dilation.The balloon was inflated once at 8 atm; however, the balloon did not properly inflate.Negative pressure was applied for 3 to 5 seconds; however, the balloon was slow to deflate.Eventually, the balloon was successfully deflated and removed.An additional trek bdc was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 24621326
• Report Number: 2024168-2026-01060
• Device Sequence Number: 21229031
• Product Code: LOX
• UDI-Device Identifier: 08717648138287
• UDI-Public: (01)08717648138287(17)260831(10)30906G2
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K180040
• 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): 04/09/2026

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: 08/31/2026
• Device Model Number: 1012272-12
• Device Catalogue Number: 1012272-12
• Device Lot Number: 30906G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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
• Patient Sex: Unknown