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

Model Number 1012270-15

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was not returned to abbott vascular for analysis.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 incidents reported from this lot.In this case, the device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use.It should be noted that the instructions for use (ifu), for the trek rx and mini trek rx, states: balloon pressure should not exceed the rated burst pressure (rbp).Use of a pressure-monitoring device is recommended to prevent over-pressurization.In this case, the reported ifu violation does not appear to have caused or contributed to the reported complaint.The investigation determined the reported difficulty to advance and balloon rupture appears to be related to operational circumstances of the procedure.In this case, based on the reported information, it is likely that during advancement and/or inflation, the balloon outer surface became compromised and/or damaged against the heavily calcified, mildly tortuous, 90% stenosed anatomy resulting in the balloon rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the heavily calcified, mildly tortuous, 90% stenosed right coronary artery.A 2x15mm mini trek balloon dilatation catheter (bdc) was advanced with resistance with the anatomy.During the first inflation, the balloon ruptured at 16 atmospheres.An unspecified balloon and stent were used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10706165
• MDR Text Key: 212139260
• Report Number: 2024168-2020-08731
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138157
• UDI-Public: 08717648138157
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 1012270-15
• Device Catalogue Number: 1012270-15
• Device Lot Number: 00506G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1