MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-20
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nathe device was received.The 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 on (b)(6) 2020, percutaneous intervention was performed on the saphenous vein graft (svg) to right coronary artery.During advancement of the trek balloon dilatation catheter, within a 6french guideliner, resistance was met and the trek balloon separated.The device had not yet exited the guideliner into the artery.The guideliner containing the trek device and separated balloon, was removed from the patient.There was no adverse patient effect.No additional information as provided regarding this issue.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment due to the condition of the returned device.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.Resistance with the guiding catheter usually occurs because either the device is not coaxially aligned, meaning it¿s not inserted straight, so it interacts with the guiding catheter, or the shape of the anatomy can angle the guiding catheter such that the device bumps into it, causing resistance.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the guiding catheter resulted in the reported difficult to advance.Manipulation of the device resulted in the noted device damages (stretched/wrinkled/bunched inner member and outer member, multiple hypotube bends) and ultimately resulted in the reported/noted material separations (inner/outer member).Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10785729
• Report Number: 2024168-2020-09221
• Device Sequence Number: 3644723
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 01/11/2021

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: 09/30/2022
• Device Model Number: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 91002G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/11/2021
• 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: 7 FRENCH GUIDE CATHETER; SION BLUE GUIDE WIRE; 7 FRENCH GUIDE CATHETER; SION BLUE GUIDE WIRE
• Patient Age: 73 YR