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

Model Number	1012447-20
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	12/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a percutaneous coronary intervention was performed on the right coronary artery (rca), heavily calcified lesion.An nc trek advanced to the lesion without an issue noted.Four inflations were performed at 18, 20, 22, and 26 atmospheres (atms).On the fourth inflation at 26 atms, the balloon ruptured.The device was removed without issue.There was no other device issue.There were no adverse patient effects and there was no clinically significant delay associated.Another device was successfully used in replacement.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was discarded and is not returning for analysis.The investigation is not yet complete.A follow up report will be submitted with all additional relevant information.(b)(4).
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 four inflations were performed at 18, 20, 22, and 26 atmospheres (atms) with the nc trek.On the fourth inflation at 26 atms, the balloon ruptured.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm.In this case, it is likely the combination of the ifu deviation and the heavily calcified anatomy resulted in the reported balloon rupture.The investigation determined the reported balloon rupture appears to be related to user error/operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 13044502
• Report Number: 2024168-2021-11894
• Device Sequence Number: 16592465
• Product Code: LOX
• UDI-Device Identifier: 08717648151774
• UDI-Public: 08717648151774
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 01/31/2024
• Device Model Number: 1012447-20
• Device Catalogue Number: 1012447-20
• Device Lot Number: 10223G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 83 KG