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

Model Number	1012453-15
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
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: medical device problem code 2017 - failure to follow steps / instructions / incorrect prep.
Event or Problem Description
It was reported that the procedure was to treat the left main coronary artery with 90% stenosis.During the procedure, the 4.0x15 mm nc trek balloon dilatation catheter (bdc) inflated twice to 8 atmospheres without issue; however, the balloon failed to deflate.Negative pressure was held for 5 seconds.The balloon was removed with the guiding catheter due to resistance between the devices as the balloon completely failed to deflate.The balloon was reportedly not prepped (air aspiration) outside of the anatomy prior to use.A new guiding catheter and balloon were used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional, and functional inspections were performed on the returned device.The reported failure to deflate was not confirmed.The reported failure to deflate could not be replicated in a testing environment due to the condition of the returned device.The production record and corrective and preventive 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 balloon was removed fully inflated.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.In this case, it is likely that the ifu violation contributed to the reported difficulty removing the device.Additionally, it was reported that the device was not prepped outside of the patient anatomy.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use 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 violation of the ifu caused or contributed to the reported complaint.Based on the reported information and results of the complaint investigation, there is no indication that the reported failure to deflate or difficulty removing the device are related to a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported difficulty removing the device appears to be related to operational context.Possible factors that may contribute to failure to deflate 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.Additionally, it is likely that the reported failure to deflate contributed to the reported resistance met during removal since the balloon would not fully deflate.

• 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: 19568848
• Report Number: 2024168-2024-07403
• Device Sequence Number: 12503277
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: (01)08717648152078(17)260331(10)30412G2
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 03/31/2026
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 30412G2
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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