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

Model Number	1012274-25
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
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 additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2020, a percutaneous coronary intervention was performed within the right coronary artery (rca), heavily calcified lesion.A trek dilatation catheter advanced with unusual resistance felt due to anatomy.Inflation was performed to 16 atmospheres when the balloon ruptured.During trek removal, unusual resistance was felt with anatomy and the shaft separated into two pieces.All was removed as a single unit and nothing from the device was left in the anatomy.There was no adverse patient sequela and there was no clinically significant delay.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
Visual and scanning electron microscopy (sem) inspection/analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty advancing and removing the device could not be replicated in a testing environment as it was based on operational circumstances.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.It was reported that the balloon dilatation catheter was overinflated to 16 atmospheres (atms) when the balloon ruptured.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the trek rx device is 14 atm; therefore, rbp was exceeded.The investigation determined the reported balloon rupture appears to be related to user error/operational context; however, the reported separation, difficulty advancing and removing the device appear to be related to operational context.Based on the information reviewed, there is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: device code 2524 removed.

• 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: 9753602
• Report Number: 2024168-2020-01769
• Device Sequence Number: 14004471
• Product Code: LOX
• UDI-Device Identifier: 08717648138454
• UDI-Public: 08717648138454
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/13/2020

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: 07/31/2022
• Device Model Number: 1012274-25
• Device Catalogue Number: 1012274-25
• Device Lot Number: 90809G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/13/2020
• 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: ASAHI BLUE GUIDE WIRE; ASAHI BLUE GUIDE WIRE
• Patient Age: 58 YR
• Patient Weight: 110