MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-15
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	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending artery (lad) with none tortuosity and none calcification.The 2.50x15mm trek balloon dilatation catheter (bdc) was inflated once when a rupture occurred at 16 atmospheres.Therefore, another 3.50x15mm trek bdc was inflated; however, a rupture occurred in the first inflation at 15 atmospheres.Another two trek balloons were used to completed the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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 identified no other similar incidents and/or complaints from this lot.It was reported that the balloon was overinflated to 16 atmospheres (atms) when the balloon ruptured.It should be noted that the coronary dilatation catheters, 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.In this case, it could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture.The investigation was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Medical device problem code 2017: improper or incorrect procedure or method the additional trek device(s) referenced in b5 is/are filed under separate medwatch report number(s).¿.

• 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: 17201213
• Report Number: 2024168-2023-06762
• Device Sequence Number: 12462048
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: 08717648138577
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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: 12/31/2025
• Device Model Number: 1012276-15
• Device Catalogue Number: 1012276-15
• Device Lot Number: 30119G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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