MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Catalog Number	1012447-12
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Leak/Splash (1354); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion in a very tortuous vessel and this was a myocardial infarction case.Two other balloons were attempted but could not advance.The 2.5x12 mm nc trek balloon was not soaked prior to use and was noted to have a loose shaft and leaking air during inflation and could not be inflated during the only attempt to inflate the device.When the device was being placed back into the dispenser hoop the shaft separated.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.A non-abbott balloon was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 - incorrect prep.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported separation was confirmed.The reported break, inflation issue and leak could not be determined since only a partial portion of the device was returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported that the balloon was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the violation of the ifu caused or contributed to the reported complaint.The investigation determined the reported break, separation, inflation issue and leak appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 17990889
• Report Number: 2024168-2023-11742
• Device Sequence Number: 8199175
• Product Code: LOX
• UDI-Device Identifier: 08717648151750
• UDI-Public: 08717648151750
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K103153
• 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): 12/29/2023

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: 12/31/2025
• Device Catalogue Number: 1012447-12
• Device Lot Number: 30130G1
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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