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

Model Number	1012276-15
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
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.D4: the udi number is not known as the part and lot number were not provided.H6: medical device problem code 2017 - use after damage.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified and moderately tortuous lesion in the left anterior descending artery (lad).A 3.5x15mm trek rx balloon dilatation catheter (bdc) was advanced into the anatomy through resistance; however, a kink was noted and the device was removed.The bdc was attempted to be reinserted into the anatomy, however, the shaft was noted to separate during advancement before entering the anatomy.A new balloon catheter was used and the procedure was completed.There was no reported adverse patient effects nor clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported kink and separation were confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances.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 by the account that the shaft was noted to be kinked and it was still attempted to be reinserted into the anatomy and the shaft ultimately separated.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use (ifu) states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.Instead, prepare a new catheter.In this case, it is likely that the attempt to reinsert the kinked shaft back into the anatomy, contributed to the reported separation.Based on the reported information and the observations from the returned device analysis, the investigation determined that the reported difficulty advancing the device and kink appear to be related to operational context; however, the reported separation appears to be related to user error/operational context.There was no damage noted to the balloon dilatation catheter (bdc) during the inspection prior to use, which suggests a product quality issue did not contribute to the reported difficulties.It was reported by the account that the bdc interacted with the moderately tortuous and heavily calcified anatomy resulting in the reported difficulty advancing the device and subsequently the shaft became kinked.The device was removed, and it was attempted to be reinserted and the shaft ultimately separated, likely due to handling as a kink was already noted.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Additional information: d4: catalog# updated from unk nc trek rx to 1012276-15.Lot# updated from unknown to: 40203g1.Primary udi number updated from unknown to (b)(4).

• 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: 20930268
• Report Number: 2024168-2024-14733
• Device Sequence Number: 8285662
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: (01)08717648138577(17)270131(10)40203G1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/23/2025

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: 1012276-15
• Device Catalogue Number: 1012276-15
• Device Lot Number: 40203G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2024
• 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