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

Model Number	1012454-20
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when attempting to advance a 4.5x20mm nc trek balloon dilatation catheter (bdc) it would not advance.During removal the bdc met resistance with the.014 balance middleweight universal ii guide wire.It was noted that both devices had to be removed together as one unit.On the guide wire a small relief [unknown damage] was observed just before the beginning of the radiopaque mark and the shaft of the bdc was noted to be damaged.Another guide wire and balloon were used to successfully complete the procedure.There was no adverse patient effect reported and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional device referenced in b5 is filed under a separate medwatch report number.
Additional Manufacturer Narrative
Visual inspection, functional testing and dimensional analysis were performed on the returned device.The reported unknown damage was confirmed as a tear/hole was noted on the returned device.The reported difficulty advancing and removing the device onto the guide wire could not be confirmed.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 unknown damage, difficulty advancing and removing the device onto the guide wire could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Returned device analysis noted that the nc trek balloon outer member returned torn and the balance middleweight universal ii guide wire polymer coating was separated: however, still held by the guide wire core.No additional information was provided.

• 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: 19628037
• Report Number: 2024168-2024-07743
• Device Sequence Number: 8610079
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: (01)08717648152122(17)260131(10)30208G1
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 01/31/2026
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 30208G1
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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: .014 BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE.
• Patient Sex: Unknown