MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK RX OTW LIMITED INDICATION; CORONARY DILATATION CATHETER

Model Number	1012402-08A
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported failure to advance and difficulty removing the device 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.
Event or Problem Description
It was reported that the procedure was to treat a chronically totally occluded left anterior descending artery.The patient was treated with a guide wire that crossed to the lesion antegradely, then a non-abbott 1.0 mm balloon dilatation catheter crossed the lesion.After that, a mini trek ii (otw) balloon was attempted to be advanced but failed to cross due to the anatomy.During removal, resistance with anatomy was also met.A new non-abbott 1.5 mm balloon dilatation catheter (rx) was replaced to continue the procedure successfully.There were no adverse patient effects and no clinically significant delay was noted.No additional information was provided.

• Brand Name: MINI TREK RX OTW LIMITED INDICATION
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11174505
• Report Number: 2024168-2021-00460
• Device Sequence Number: 3648942
• Product Code: LOX
• UDI-Device Identifier: 08717648180811
• UDI-Public: 08717648180811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110617
• 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
• Report Date (Section B): 01/14/2021

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: 11/30/2022
• Device Model Number: 1012402-08A
• Device Catalogue Number: 1012402-08A
• Device Lot Number: 91206G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1