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

Model Number	1012449-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.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.
Event or Problem Description
It was reported that this was a percutaneous coronary intervention treating the proximal left circumflex (cx) lesion.An unspecified stent was implanted in the proximal cx.Post-dilatation was performed using an nc trek for two inflations (10 atms for 11 seconds, 10 atms for 20 seconds) without issues.After the third inflation (15 atms for 12 seconds), the balloon was unable to deflate.Negative was pulled greater than 30 seconds and the balloon partially deflated.The nc trek was retracted into the guide catheter and all (guide catheter, nc trek, guidewire) was removed as a single unit.Once outside the anatomy, the nc trek was unable to be removed from the guide catheter.There was no damage noted to the implanted stent and no damage to the vessel.There was no adverse patient effect and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported deflation issue and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Device code 2017- failure to follow steps/instructions.The device was prepped in the patient's anatomy.

• 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: 9500970
• Report Number: 2024168-2019-14816
• Device Sequence Number: 2001957
• Product Code: LOX
• UDI-Device Identifier: 08717648151880
• UDI-Public: 08717648151880
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 06/30/2022
• Device Model Number: 1012449-20
• Device Catalogue Number: 1012449-20
• Device Lot Number: 90724G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 75