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

Model Number	1012450-15
Medical Device Problem Codes	Product Quality Problem (1506); Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event estimated date.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left circumflex.A 3.25x15mm nc trek rx balloon dilatation catheter (bdc) was damaged while trying to cross.The method used to complete the procedure was not provided.There was no reported clinically significant delay in the procedure and no reported adverse patient effects.During inventory of the returned device, a hypotube separation was observed.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported product quality problem/unknown damage was able to be confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling/manipulation of the device during advancement resulted in the noted multiple hypotube bends and ultimately resulted in the reported product quality problem/noted hypotube separation; thus resulting in the reported failure to advance.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 2889 was removed.

• Brand Name: NC TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9788144
• Report Number: 2024168-2020-02008
• Device Sequence Number: 11229070
• Product Code: LOX
• UDI-Device Identifier: 08717648151934
• UDI-Public: 08717648151934
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 01/31/2022
• Device Model Number: 1012450-15
• Device Catalogue Number: 1012450-15
• Device Lot Number: 90205G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1