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

Model Number	1012455-15
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
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 to treat the right coronary artery (rca) with 70% stenosis.An unspecified stent was implanted and the 5.0x15 mm nc trek balloon dilatation was used for post-dilatation.After inflation the balloon did not deflate properly and could not enter the 6fr therapeutic catheter.Numerous attempts were made to remove without success and then the shaft of the balloon broke.The entire catheter system was attempted to be removed with the guide wire and the introducer sheath but again this was unsuccessful.The 6fr introducer sheath was removed from the right radial artery due to the balloon being stuck in the introducer sheath.Only by removing the introducer sheath, leaving the radial artery free, was it possible to remove the balloon from the radial artery.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported break was not confirmed; however, it is likely that the noted separation at the inner and outer member is what was perceived as the reported break.The reported failure to deflate and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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, a definitive cause for the reported failure to deflated could not be determined; however, the reported difficulty removing the device, break/separation and unexpected medical intervention appear to be related to circumstances of the procedure.Possible factors that may contribute to failure to deflate the balloon include, but are not limited to, deflation technique, loose connection with the indeflator, contrast concentration, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.In this case, it is likely that since the balloon would not deflate, the balloon dilatation catheter became stuck, resulting in the reported difficulty removing the device and subsequently upon manipulation of the device, the device ultimately broke/separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: NC 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: 20746706
• Report Number: 2024168-2024-13799
• Device Sequence Number: 8362983
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: (01)08717648152153(17)260228(10)30308G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K110134
• 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): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 30308G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown