MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-12
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported complaint appears 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.It was reported that the balloon was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.Additionally, the device was not prepared (air aspiration) outside the anatomy.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the violations of the ifu caused or contributed to the reported complaint.
Event or Problem Description
It was reported that the procedure was to treat the proximal right coronary artery (rca) with moderate calcification and mild tortuosity.The 3.5x12 mm nc trek balloon dilatation catheter (bdc) was not soaked in saline prior to use and was prepped inside the anatomy.During the 3rd inflation to 10 atmospheres for 10 seconds, the balloon ruptured.An unspecified balloon was used to complete the procedure.There were no averse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: 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: 15588260
• Report Number: 2024168-2022-10563
• Device Sequence Number: 11465659
• Product Code: LOX
• UDI-Device Identifier: 08717648138560
• UDI-Public: 08717648138560
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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: 10/31/2022
• Device Model Number: 1012276-12
• Device Catalogue Number: 1012276-12
• Device Lot Number: 91120G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown