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

Model Number	1012448-12
Medical Device Problem Codes	Difficult to Insert (1316); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for evaluation.It has not yet been received.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 mildly calcified left anterior artery (lad).It was noted that the 2.75x12mm nc trek's shaft was bent when removing from the packaging; however, physician decided to proceed and attempt to insert the device into a tuoghy.The shaft became separated and no retrieval process was necessary as the device had not entered the patient's anatomy.Another unspecified device was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 identified no other similar incidents and/or complaints from this lot.It was reported by the account that the balloon dilatation catheter (bdc) was inadvertently kinked when removing from the packaging; however, physician decided to proceed and attempt to insert the device into a tuoghy.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: 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.In this case, it is likely that the use of the kinked shaft contributed to the reported difficulty inserting the device into the tuoghy and the shaft separation, as the device was further manipulated at the kinked location.The investigation determined the reported kink appears to be related to operational context; however, the reported difficulty inserting the device and shaft separation appear to be related to user error.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of this device.D9: device available for eval updated from "yes" to "no".H3: reason device not evaluated by mfg changed to na.H6: 4582 code was added.

• 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
• MDR Report Key: 11764269
• Report Number: 2024168-2021-03728
• Device Sequence Number: 4243246
• Product Code: LOX
• UDI-Device Identifier: 08717648151811
• UDI-Public: 08717648151811
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 09/30/2023
• Device Model Number: 1012448-12
• Device Catalogue Number: 1012448-12
• Device Lot Number: 01013G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR