MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012274-12
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.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 the procedure was to treat a lesion located in the circumflex artery that was non calcified and non tortuous.During advancement of the trek rx 3.00 x 12mm bdc balloon over the guide wire, markers were not observed under x-ray.Therefore, the balloon catheter was removed, and no markers were physically present.It was decided to perform direct stenting to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 complaint.However, factors that may cause the balloon marker to be missing and/or not visible under fluoroscopy include, but not limited to, manufacturing, location of anatomy and/or anatomical conditions, the type of contrast solution, contrast mixing ratio, patient anatomy, patient disease state and fluoroscopy equipment.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9, h3.The device is not available for evaluation.

• Brand Name: 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: 11852913
• Report Number: 2024168-2021-04225
• Device Sequence Number: 3576209
• Product Code: LOX
• UDI-Device Identifier: 08717648138423
• UDI-Public: 08717648138423
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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: 11/30/2023
• Device Model Number: 1012274-12
• Device Catalogue Number: 1012274-12
• Device Lot Number: 01221G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1