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

Model Number	1012448-15
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.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 (cx) artery.After laser atherectomy on the lesion, the 2.75x15mm nc trek balloon dilatation catheter (bdc) was advanced, but backflow was noted as the non-abbott bleedback valve was not tightened enough.The valve was tightened, and the backflow subsided.The bdc was then advanced, but the shaft separated because the valve was too tight.The device was removed without issue.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.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 incidents and/or complaints from this lot.It was reported by the account that the separation of the balloon dilatation catheter (bdc) shaft was due to the valve being over-tightening.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: do not torque the catheter more than one (1) full turn.It is likely that the violation of the ifu contributed to the reported shaft separation.The investigation determined the reported separation appears to be related to user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Code 2017 was added for over torqueing the device.

• 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: 11369429
• Report Number: 2024168-2021-01408
• Device Sequence Number: 3243140
• Product Code: LOX
• UDI-Device Identifier: 08717648151828
• UDI-Public: 08717648151828
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/16/2021

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: 10/31/2022
• Device Model Number: 1012448-15
• Device Catalogue Number: 1012448-15
• Device Lot Number: 91114G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1