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

Model Number	1012455-20
Medical Device Problem Codes	Deflation Problem (1149); Off-Label Use (1494)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning.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 the renal artery.A 5x20mm nc trek balloon dilatation catheter (bdc) completely failed to deflate, so a non-abbott needle device was introduced to puncture and deflate the balloon.Then the balloon was removed.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: device code 1494-incorrect anatomy.The complaint device was not returned for analysis.A review of manufacturing records could not be conducted because the lot number was not provided.It was reported that the device was used in a renal artery procedure.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: the nc trek rx coronary dilatation catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only).In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.Further investigation determined the reported deflation problem is a product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performances of these devices.

• 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: 9642397
• Report Number: 2024168-2020-00967
• Device Sequence Number: 2413893
• Product Code: LOX
• UDI-Device Identifier: 08717648152160
• UDI-Public: 08717648152160
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/11/2020

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 Model Number: 1012455-20
• Device Catalogue Number: 1012455-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROPUNCTURE NEEDLE; MICROPUNCTURE NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention