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

Model Number	1012278-30
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
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 relevant information.The viatrac plus device referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the right common carotid artery.A 5x30mm rx viatrac plus balloon dilatation catheter (bdc) met resistance with the heavy calcification during advancement and ruptured at 5 atmospheres during the first inflation.A 4.0x30mm trek rx bdc also met resistance during advancement and ruptured at 10 atmospheres during the first inflation.An 8x25mm non-abbott stent was then implanted and post-dilated to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances.It should be noted the trek rx, global, information for use (ifu), 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 and balloon dilatation of a stent after implantation.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.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 incidents/complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9759451
• Report Number: 2024168-2020-01815
• Device Sequence Number: 18987161
• Product Code: LOX
• UDI-Device Identifier: 08717648138744
• UDI-Public: 08717648138744
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: 05/31/2022
• Device Model Number: 1012278-30
• Device Catalogue Number: 1012278-30
• Device Lot Number: 90606G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1