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

Model Number	1012445-12
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Advance (2920)
Health Effect - Clinical Codes	Air Embolism (1697); Obstruction/Occlusion (2422)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a left anterior descending (lad) artery.An nc trek balloon was advanced to the target lesion, although there was some resistance met with anatomy.During the first inflation it was noted that pressure would not hold as the balloon shaft had a leak which caused an air embolism and shutdown the lad artery.Medication was provided to treat the air embolism and shutdown of the lad artery.After the procedure it was reported that the patient was doing well.There was no adverse patient sequela and no clinically significant delay.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.The reported patient effects of air embolism and occlusion are listed in the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use as known patient effects.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded the physician reported resistance delivering the balloon catheter with continued delivery.Additionally, an air embolism was noted thus indicating improper prep not seen prior to delivery.The balloon catheter ruptured with air in the balloon leading to an air embolism.Based on the conclusion from the cine, it is possible that the balloon ruptured due to interaction with the anatomy, resulting in the reported leak; however, a conclusive cause cannot be determined since the device was not returned for analysis.The investigation determined the reported difficulty advancing the device and medication requirement appear to be related to circumstances of the procedure; however, a conclusive cause for the reported leak cannot be determined.A conclusive cause for the reported patient effects of air embolism and obstruction/occlusion and the relationship to the device, if any, cannot be determined.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: 15015190
• Report Number: 2024168-2022-07694
• Device Sequence Number: 6855842
• Product Code: LOX
• UDI-Device Identifier: 08717648151644
• UDI-Public: 08717648151644
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 07/14/2022

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: 02/28/2025
• Device Model Number: 1012445-12
• Device Catalogue Number: 1012445-12
• Device Lot Number: 20326G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2022
• 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