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

Model Number 1012448-12

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

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.Na.

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, heavily tortuous right coronary artery.After an unspecified stent was implanted, a 2.75x12mm nc trek balloon dilatation catheter (bdc) failed to cross due to the anatomy, and the proximal shaft separated.The separated portion was simply withdrawn without resistance, and a 2.5x8mm nc trek balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed report, the following information was received: during prep, the balloon was slightly inflated to check for any leak.No additional information was provided.

Manufacturer Narrative

H6: device code 2017 incorrect prep.Visual inspection was performed on the returned device.The reported separation was confirmed.The reported failure to advance could not 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 of the reported lot did not indicate a lot specific quality issue.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, (repeat steps 5a through 5g, if necessary); otherwise, complications may occur.In this case, it is unknown if the ifu violation caused or contributed to the reported complaints.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Na.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11575176
• MDR Text Key: 243790293
• Report Number: 2024168-2021-02426
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151811
• UDI-Public: 08717648151811
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 1012448-12
• Device Catalogue Number: 1012448-12
• Device Lot Number: 90716G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Date Manufacturer Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1