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

Model Number	1012454-20
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	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 performed to treat a lesion in the mid right coronary artery.The nc trek dilatation catheter was prepared for use and no issues were noted.During the procedure, the balloon was inflated 1 time to 15 atmospheres without issue.The balloon was deflated, but would not deflate all the way.The partially inflated dilatation catheter was difficult to pull into the guide catheter, but was able to be pulled in and all devices were removed as a single unit.Once in the aorta, the balloon was re-inflated and was able to deflate fully.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: device code 2017: incorrect contrast to saline.Visual and functional inspections were performed on the returned section of the device; however, the reported deflation issue and difficulty to remove were unable to be confirmed as only a separated portion of the device was returned.A review of the lot history record identified one manufacturing nonconformity associated to the reported lot.Based on the review of similar incidents there is no indication of a lot specific product quality issue.It should be noted that instructions for use (ifu), cdc, nc trek rx, global, instructions for use states: 60% contrast medium diluted 1:1 with normal saline.In this case, the reported ifu violation of the incorrect contrast solution did not cause or contribute to the reported deflation issue as the contrast was not thick which would result in deflation issues.The investigation determined the reported deflation issue and difficulty to remove appear to be related to a potential quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
Event or Problem Description
Subsequent to the initial report, it was noted that the contrast to saline mix was 1:2 and should have been 1:1.No additional information was provided.

• 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: 10477551
• Report Number: 2024168-2020-07261
• Device Sequence Number: 14190385
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: 08717648152122
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/24/2020

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: 12/31/2022
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 00103G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1