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

Model Number	1012455-12
Medical Device Problem Codes	Deflation Problem (1149); 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	09/12/2024
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.H6: 2017 improper or incorrect procedure or method - failure to follow steps / instructions.
Event or Problem Description
It was reported that the procedure was to treat a dissection in the left main coronary artery (lmca).After stent implantation, the 5x12 nc trek balloon dilatation catheter (bdc) was advanced and used for post-dilatation; however, the balloon could not be completely deflated.Therefore, during removal resistance was noted with the guide catheter.It was noted that negative pressure was held for 5 seconds to deflate the balloon.The bdc and the guide catheter were removed as a single unit.It was also noted that there was resistance noted during removal of the stylet/protective sheath during preparation.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial report being filed it was reported that there was resistance noted during removal of the stylet or protective sheath and negative pressure was held for 5 seconds to deflate the balloon.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported deflation issue, difficulty removing the mandrel/stylet, protective sheath and difficult removing the device from the guiding catheter 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 deflation issue, difficulty removing the mandrel/stylet and protective sheath could not be determined; however, the reported difficulty removing the device from the guiding catheter appears to be related to circumstances of the procedure.Possible factors that can contribute to difficulty removing the mandrel/stylet may include, but not limited to, damage during protective sheath removal, removal technique or mishandling.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.Additionally, possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.Furthermore, it is likely that the reported deflation issue contributed to the resistance met with the guiding catheter during removal since the balloon would not fully deflate.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 correction: medical device problem code 2017 removed.

• 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: 20363600
• Report Number: 2024168-2024-11687
• Device Sequence Number: 20528927
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: (01)08717648152146(17)260228(10)30331G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 02/28/2026
• Device Model Number: 1012455-12
• Device Catalogue Number: 1012455-12
• Device Lot Number: 30331G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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