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

Model Number	1012451-15
Medical Device Problem Codes	Stretched (1601); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.Analysis of the returned product indicated the balloon dilatation catheter (bdc) was returned with blood on the entire length and in the guide wire lumen, with crystallized contrast on the entire length of the device and in the inflation lumen, consistent with preparation of the device and advancement in the anatomy.The balloon was tightly folded which can indicate that the balloon was never inflated, as reported.Follow up was performed with the account and they confirmed the correct device was returned.The outer and inner member were stretched distal to the mid-lap.The reported bend/kink was confirmed.The production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no other similar complaints from this lot.The investigation determined the reported bend/kink and noted stretching of the inner and outer member appear to be related to operational context.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat an 85% stenosed lesion in the left anterior descending (lad) artery with heavy calcification and moderate tortuosity.The 3.5x15mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation of an implanted stent; however, the stent was not fully expanded upon intravascular ultrasound check.The physician wanted to use the same nc trek balloon to expand the vessel again but found the shaft bent as the device was being delivered into the guiding catheter.There was no adverse patient effect reported and no clinically significant delay reported in the procedure.Return device analysis found the balloon was tightly folded.The outer and inner member were stretched distal to the mid-lap for a length of 9 centimeters (cm).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: 20304976
• Report Number: 2024168-2024-11313
• Device Sequence Number: 7744621
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: (01)08717648151989(17)260531(10)30612G2
• 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
• Report Date (Section B): 09/25/2024

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: 05/31/2026
• Device Model Number: 1012451-15
• Device Catalogue Number: 1012451-15
• Device Lot Number: 30612G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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