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

Model Number	1012274-20
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was returned for analysis.The reported material separation was able to be confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.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 did not indicate a lot specific quality issue.Reportedly, the procedure was performed to treat a lesion in the left tibial trunk.It should be noted that the trek rx and mini trek rx coronary dilatation catheter instructions for use states: the trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion.Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction.Balloon dilatation of a stent after implantation.The reported deviation of the ifu does not appear to have caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the anatomy resulting in the reported failure to advance.Manipulation of the device resulted in the noted multiple hypotube bends, the noted multiple kinks (hypotube, shaft, bayonet/support skive, outer member) and ultimately resulted in the reported material separation.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 a lesion in the left tibial trunk.A 3x20mm trek balloon dilatation catheter (bdc) faced resistance with the anatomy during advancement, and the shaft separated into two pieces.The bdc was removed without issue, and no portion of the device remains in the anatomy.An unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10690753
• Report Number: 2024168-2020-08659
• Device Sequence Number: 3058504
• Product Code: LOX
• UDI-Device Identifier: 08717648138447
• UDI-Public: 08717648138447
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• 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
• Report Date (Section B): 10/16/2020

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: 04/30/2023
• Device Model Number: 1012274-20
• Device Catalogue Number: 1012274-20
• Device Lot Number: 00529G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1