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

Model Number	1012449-20
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.(b)(4).
Event or Problem Description
It was reported that this was a csi atherectomy procedure and atherectomy and stenting had been performed in the left anterior descending (lad) coronary artery with stenosis and calcification.The nc trek balloon dilatation catheter (bdc) was prepped and during advancement on the guide wire without resistance, the shaft became kinked before entering the patient.The device was used anyway and during advancement there was slight resistance with the anatomy and the shaft separated.The proximal portion was simply withdrawn but the distal portion was removed when it was trapped by an additional bdc.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The balloon dilatation catheter (bdc) was not returned for analysis.Based on the report information the account damaged the device during prep.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints.The reported event stated the balloon was inflated to 20atms.It should be noted that instructions for use (ifu), "prior to use examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.¿ it is likely the ifu violations contributed to the reported difficulties.Based on the information provided the cause for reported the difficulties was due to use error.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D10, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was retained by hospital and is not available for evaluation.

• 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: 15915753
• Report Number: 2024168-2022-12222
• Device Sequence Number: 15089096
• Product Code: LOX
• UDI-Device Identifier: 08717648151880
• UDI-Public: 08717648151880
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 1012449-20
• Device Catalogue Number: 1012449-20
• Device Lot Number: 20928G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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: UNSPECIFIED GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown