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

Model Number	1012268-12U
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.It is possible that a buildup of blood and/or contrast on the guide wire resulted in the reported difficult to remove; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional mini trek device mentioned is being filed under a separate medwatch number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mildly tortuous right coronary artery (rca).The 1.2x12 mm trek balloon dilatation catheter (bdc) was used in the rca and then after inflation it was noted that the bdc could not move back on the guide wire so the bdc was removed.Another 2.0x15 mm mini trek bdc was used in the rca and after inflation it was noted the bdc could not move back on the guide wire so another bdc was used to complete the procedure.There were no issues with inflation or deflation with either balloon.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MINI 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: 10207372
• Report Number: 2024168-2020-05404
• Device Sequence Number: 14270486
• Product Code: LOX
• UDI-Device Identifier: 08717648176555
• UDI-Public: 08717648176555
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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 Model Number: 1012268-12U
• Device Catalogue Number: 1012268-12U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1