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

Model Number	1012450-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
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 was unable to determine a conclusive cause for the reported balloon rupture.However, possible factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, inflation technique, interactions with other devices or patient anatomy.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 90% stenosed lesion in the mid right coronary artery with mild calcification and mild tortuosity.The 3.25x15mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion and the balloon was inflated; however, a ruptured occurred during the first inflation at 10 atmospheres (atm).Therefore, the bdc was removed from the patient.There was no adverse patient effect and no clinically significant delay reported in the procedure.A non-abbott balloon was used to continue the procedure.No additional information was provided.

• Brand Name: NC 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: 17042282
• Report Number: 2024168-2023-05756
• Device Sequence Number: 8784104
• Product Code: LOX
• UDI-Device Identifier: 08717648151934
• UDI-Public: 08717648151934
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103153
• 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): 06/01/2023

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: 05/31/2025
• Device Model Number: 1012450-15
• Device Catalogue Number: 1012450-15
• Device Lot Number: 20606G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2022
• 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