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

Model Number	1012451-20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Air Embolism (1697); Angina (1710)
Date of Event	11/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal right coronary artery (rca) to the posterior descending artery (pda) with moderate calcification and moderate tortuosity.The 3.50x20mm nc trek balloon dilatation catheter (bdc) was prepped without issue and then advanced to the target lesion.When attempting to inflate the balloon the needle on the indeflator indicated that the balloon would not maintain pressure.Air bubbles were noted in the artery and the patient experience chest pain due to the air embolus.Therefore the physician administered multiple rounds of intracoronary adenosine and an integrilin bolus.The air emboli worked its way out through capillaries and blood flow was re-established.No further treatment was provided and the patient was discharged from the hospital.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections was performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 angina are listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) as known patient effects.The investigation determined the reported balloon rupture appears to be related to operational context and the reported medication appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of air embolism and angina 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: 15875055
• Report Number: 2024168-2022-11971
• Device Sequence Number: 16767278
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/16/2022

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: 12/31/2024
• Device Model Number: 1012451-20
• Device Catalogue Number: 1012451-20
• Device Lot Number: 20114G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2022
• 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 Age: 49 YR
• Patient Sex: Male