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

Model Number	1012449-15
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, moderately tortuous left anterior descending artery.The 3.0x15mm nc trek balloon dilatation catheter became stuck with the hi-torque balance middleweight universal ii guide wire when attempting to advance over the wire.With a little force the shaft of the guide wire separated when attempting to remove.The balloon and guide wire were removed as a unit; the separated portion was removed via snare.A non-abbott device was used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information provided, a definitive cause for the reported complaints could not be determined.Possible factors that may contribute to the difficult advancing and removing the balloon dilatation catheter (bdc) from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, device placement technique, buildup of procedural contaminants in the guide wire lumen, guiding catheter support, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.In this case, a conclusive cause for the reported complaints could not be determined since the device or component were not returned for analysis.Based on the results of the complaint investigation, 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: 20641183
• Report Number: 2024168-2024-13128
• Device Sequence Number: 17984435
• Product Code: LOX
• UDI-Device Identifier: 08717648151873
• UDI-Public: (01)08717648151873(17)261130(10)31214G1
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• 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
• Report Date (Section B): 11/08/2024

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 Model Number: 1012449-15
• Device Catalogue Number: 1012449-15
• Device Lot Number: 31214G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• 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: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian