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

Model Number	1012454-20
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is returning for analysis; however, has not been received yet.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was to treat a left anterior descending artery.During the procedure the 4.5x20mm nc trek balloon dilatation catheter (bdc) was inflated to 14 atmospheres; however, did not deflate.It was noted the balloon became stuck in the right radial artery as it was removed inflated.The unspecified guide catheter and guide wire had to be removed first, then the bdc was removed with difficulty.No other device was used to complete the procedure.There was no adverse effects reported and no clinically significant delay reported.No additional information was provided.
Event or Problem Description
It was reported the procedure was to treat a left anterior descending artery.During the procedure the 4.5x20mm nc trek balloon dilatation catheter (bdc) was inflated to 14 atmospheres; however, did not deflate.It was noted the balloon became stuck in the right radial artery as it was removed inflated.The unspecified guide catheter and guide wire had to be removed first, then the bdc was removed with difficulty.No other device was used to complete the procedure.There was no adverse effects reported and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported failure to deflate was not confirmed.The reported difficulty to remove could not be replicated in a testing environment as it was based on circumstances of the procedure.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 investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported difficulty removing the device appears to be related to circumstances of the procedure.Possible factors that may contribute to failure to deflate include, but are not limited to, deflation technique, tortuous anatomy, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.A conclusive cause for the reported failure to deflate could not be determined since the complaint could not be confirmed during return analysis.Furthermore, it is likely that the balloon failure to deflate contributed to the reported difficulty removing the device.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: 15970574
• Report Number: 2024168-2022-12572
• Device Sequence Number: 11996505
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: 08717648152122
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: 06/30/2025
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 20701G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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
• Patient Sex: Unknown