MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

Catalog Number	1012450-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: a visual inspection was performed on the returned device and the shaft separation was confirmed.The reported difficulty to position and remove the device was unable to be replicated in a testing environment as it was based on operational circumstances.The investigation determined the reported difficulty to position, difficulty to remove and shaft separation appear to be related to circumstances of the procedure as reported.It should be noted that the nc trek rx instructions for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, although it was reported that the physician used force to remove the device, this was due to the balloon interacting with the second unknown bdc; therefore the force applied during removal of the devices seemed to be a reasonable clinical response to the difficulties.In this case, based on the reported information, it is likely that during advancement the balloon dilatation catheter (bdc) and unspecified bdc became tangled in the guiding catheter causing the reported resistance.Additional manipulation and/or mishandling of the devices likely resulted in the guide wire notch stretching and the hypotube to kink ultimately resulting in the reported shaft separation during retraction.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 from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat an 80% stenosed, mildly tortuous, and moderately calcified lesion in the mid left anterior descending artery.A kissing technique attempt was made by advancing a 3.25x12mm nc trek balloon dilatation catheter (bdc) and another unspecified bdc; however, resistance advancing the 3.25x12mm nc trek bdc was felt with the unspecified bdc.The balloons became stuck and resistance removing the nc trek bdc was felt with the other bdc.Force was applied and the shaft separated.The bdc did not exit the guide catheter into the coronary anatomy; therefore, hemostats were used to remove the separated portion.The procedure was successfully completed with a non-abbott bdc.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7962561
• Report Number: 2024168-2018-07899
• Device Sequence Number: 11197417
• Product Code: LOX
• UDI-Device Identifier: 08717648151927
• UDI-Public: 08717648151927
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2018

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: 02/28/2021
• Device Catalogue Number: 1012450-12
• Device Lot Number: 80324G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention