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

Model Number	1012453-20
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Angina (1710)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during a moderately calcified obtuse marginal and circumflex artery intervention, the 4.0x20mm nc trek balloon dilatation catheter (bdc) was advanced to the lesions without issue and pre-dilatation was successfully completed.After removal of the bdc, unspecified stents were implanted.The bdc was inserted into the anatomy again and advanced to perform post-dilatation in the cx artery.The balloon was inflated without issue, but could not be deflated.Trouble shooting was performed, but the balloon failed to deflate and the patient developed chest pain.The bdc, guidewire and sheath were removed as a single unit and the chest pain resolved.The procedure was deemed successful and was done.There was no adverse patient sequela.A replacement device was not needed as post-dilatation was complete at this point and the target lesions were already treated.The pt is stable.Although there was a 10-15 min delay, it was not clinically significant.The pt was discharged the next day as planned.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device.The reported failure to deflate could not be 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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported minor injury/ illness / impairment [angina] appears to be related to circumstances of the procedure.The reported patient effect of angina is listed in the coronary dilatation catheters (cdc), nc trek rx instructions for use as a known patient effect.A conclusive cause for the reported patient effect of angina and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.B1: adverse event/product problem - adverse event was removed.B2: outcomes attributed to ae - other serious was changed to na.H1: type of reportable event - serious injury was changed to malfunction.H6: patient code 4604 was removed.

• 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: 16587200
• Report Number: 2024168-2023-02935
• Device Sequence Number: 5015202
• Product Code: LOX
• UDI-Device Identifier: 08717648152085
• UDI-Public: 08717648152085
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/05/2023

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: 09/30/2025
• Device Model Number: 1012453-20
• Device Catalogue Number: 1012453-20
• Device Lot Number: 21019G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 136 KG