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

Model Number	1012449-12
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation of the 3.0x12 mm nc trek balloon dilatation catheter (bdc), when swabbing the shaft of the device with saline, the device separated into 2 pieces.Preparation was performed per the instructions for use.There was no device use or patient involvement.A non-abbott balloon was used to complete the procedure.There was no reported clinically significant delay in the procedure.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.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported separation 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 review of the complaint history identified no other similar complaints from this lot.The investigation determined the reported separation appears to be related to operational context.There was no damage noted to the bdc during the inspection prior to preparation which suggests a product quality issue did not contribute to the reported difficulty.Returned device analysis noted that the fractured faces of the hypotube were oval shaped which can indicate the hypotube was kinked and then separated.In this case, it is likely that the device was inadvertently mishandled during preparation, such that the bdc became kinked and upon further manipulation the bdc ultimately separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Additional information: d4 - model # added.Corrections: d1 - brand name updated.D2a - common device name updated.D3 - name updated.D3 - address, city, postal code updated.

• 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: 18975252
• Report Number: 2024168-2024-03625
• Device Sequence Number: 15126888
• Product Code: LOX
• UDI-Device Identifier: 08717648151866
• UDI-Public: (01)08717648151866(17)260930(10)31018G2
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/12/2024

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: 09/30/2026
• Device Model Number: 1012449-12
• Device Catalogue Number: 1012449-12
• Device Lot Number: 31018G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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