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

Model Number	1012404-08
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Off-Label Use (1494); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
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 during preparation of the 2.25x8mm trek balloon dilatation catheter (bdc), a the shaft was noted to have a break as fluid was leaking from the shaft.The bdc was not used in the procedure.There was no patient involvement and no clinically significant delay reported in the procedure.Return device analysis found the balloon dilatation catheter (bdc) was returned with blood in the guide wire lumen.There was dried contrast in the inflation lumen.The balloon was loosely folded.There was no adverse patient effect reported.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported leak, wrinkled device damage and tear in the outer member were 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.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported complaints appear to be related to circumstances of the procedure.Per indications section, states: the coronary dilatation catheter (cdc), trek over the wire (otw) and mini trek otw is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.Balloon dilatation of a stent after implantation (balloon models 2.00 mm¿5.00 mm only).In this case, it is unknown if the instructions for use (ifu) violation contributed to the reported complaint because abbott has not evaluated this use.There was no leak noted during preparation, during the first inflation or damage noted during inspection prior to use, which suggests a product quality issue did not contribute to the reported difficulties.Return device analysis confirmed the reported wrinkled balloon and inner member as well as the reported tear in the outer member.In this case, it is likely that the reported wrinkled damage on the device resulted from inadvertent manipulation of the device during the procedure or removal.Based on the returned condition of the device and what was reported, it is likely that the device was inadvertently mishandled and/or interacted with lab equipment and/or accessory device during the procedure such that the outer member became damaged (torn), which subsequently resulted in the reported leak.H6 - adverse event problem medical device problem code 1069 removed.
Event or Problem Description
Subsequent to the initial report being filed, it was reported that the2.25x8mm trek balloon dilatation catheter (bdc) was used in the procedure in the marshall vein.At the target lesion the balloon was inflated; however, during the second inflation, the shaft of the bdc leaked.The outer member of the bdc shaft was noted to become torn and the outer member of the bdc and balloon were noted to be wrinkled.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: 23306225
• Report Number: 2024168-2025-11134
• Device Sequence Number: 4967446
• Product Code: LOX
• UDI-Device Identifier: 08717648153891
• UDI-Public: (01)08717648153891(17)270930(10)41025G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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 Model Number: 1012404-08
• Device Catalogue Number: 1012404-08
• Device Lot Number: 41025G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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