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

Model Number	1012276-15
Medical Device Problem Codes	Deflation Problem (1149); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mid to distal right coronary artery (rca) lesion.The 3.50x15mm trek rx balloon dilatation catheter (bdc) was not prepped outside the anatomy prior to use.The trek was advanced and inflated with no issues; however, the balloon only partially deflated.Upon removal of the partially deflated balloon, the whole balloon was noted to be missing.Angiography was performed and it was confirmed that the balloon was not in the anatomy.It was noted that the balloon may have come off on the table.There were no adverse patient effects and no clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.The reported separation was confirmed.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 did not deflate resulting in the balloon being removed partially inflated.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use (ifu) states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.Additionally, it was reported that the device was not prepared outside the anatomy.The ifu also specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the ifu violations contributed to the reported complaint.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported deflation issue could not be determined; however, the reported separation appears to be related to circumstances of the procedure.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, manufacturing, deflation technique, tortuous anatomy, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.A conclusive cause for the reported deflation issue could not be determined due to the condition of the returned device.It was reported by the account that the physician mentioned that it was possible the balloon came off on the table and not inside the patient.In this case, it is possible that the balloon separated due to manipulation after the procedure.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: incorrect prep, incorrect removal.

• 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: 24581604
• Report Number: 2024168-2026-01011
• Device Sequence Number: 16050172
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: (01)08717648138577(17)280229(10)50326G1
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Report Date (Section B): 03/12/2026

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 Model Number: 1012276-15
• Device Catalogue Number: 1012276-15
• Device Lot Number: 50326G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2025
• 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 Age: 76 YR
• Patient Sex: Male