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

Model Number	1012454-08
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the proximal right coronary artery with history of a dissection.The 4.5x8 mm nc trek balloon dilatation catheter (bdc) was inflated 3 times to 20 atmospheres but was not possible to deflate during the procedure.Negative pressure was held, then the device re-inflated, and negative pressure held again and this was repeated.The balloon was brought to the aorta and inflated until it ruptured.The balloon was retrieved with a guideliner and a sheathless catheter.There was a delay in the procedure but no harm to the patient.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Subsequent to the initially filed eumir report, the following information was provided: the procedure was to treat a lesion in the proximal right coronary artery with history of a dissection.The balloon was inflated 3 times to 20 atmospheres.Negative pressure was held, then the device re-inflated, and negative pressure held again and this was repeated.There was no harm to the patient due to the 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 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 device is 18 atm; therefore, rbp was exceeded.In this case, it is unknown if the ifu violation caused or contributed to the reported compliant.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported unexpected medical intervention appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.D10, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• 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: 16247910
• Report Number: 2024168-2023-00857
• Device Sequence Number: 20411458
• Product Code: LOX
• UDI-Device Identifier: 08717648152092
• UDI-Public: 08717648152092
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 1012454-08
• Device Catalogue Number: 1012454-08
• Device Lot Number: 20927G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown