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

Model Number	1012454-08
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported that the procedure was to treat a lesion in the left anterior descending artery with moderate calcification and moderate tortuosity.The 4.5x8mm nc trek rx balloon dilatation catheter (bdc) was used to post dilate a stented lesion and was inflated 7-8 times up to 24 atmospheres.Negative was held to deflate the balloon for 5 seconds.The balloon was unable to fully deflate post dilatation.The balloon was attempted to be pulled back into the guide catheter and it was not able to pass through and got partially stuck.The balloon and the guide catheter were then removed as a unit.There was no difficulty removing the stylet or protective sheath and the device was prepared (air aspiration) outside the anatomy prior to use.The contrast mix was omipaque 50% and saline 50%.There was no adverse patient effect and there was no clinically delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported deflation issue could not be confirmed; however, the reported difficulty removing the device was confirmed.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 was reported that the nc trek bdc was overinflated 7-8 times to 24 atmospheres (atms).It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm.In this case, it is unknown if the ifu violation caused or contributed to the reported complaints.The investigation was unable to determine a conclusive cause for the reported deflation issue and difficulty removing the device from the guiding catheter.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.Additionally, possible factors that can contribute to difficult to remove/resistance with the guiding catheter post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends or procedural technique.In this case, a conclusive cause for the reported deflation issue and difficulty removing the device from the guiding catheter could not be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending artery with moderate calcification and moderate tortuosity.The 4.5x8mm nc trek rx balloon dilatation catheter (bdc) was used to post dilate a stented lesion and was inflated 7-8 times up to 24 atmospheres.Negative was held to deflate the balloon for 5 seconds.The balloon was unable to fully deflate post dilatation.The balloon was attempted to be pulled back into the guide catheter and it was not able to pass through and got partially stuck.The balloon and the guide catheter were then removed as a unit.There was no difficulty removing the stylet or protective sheath and the device was prepared (air aspiration) outside the anatomy prior to use.The contrast mix was omipaque 50% and saline 50%.There was no adverse patient effect and there was no clinically delay in the procedure.Subsequent to the initially filed report, the following information was provided: the balloon only partially deflated on the last deflation.No additional information was provided.

• 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: 16095205
• Report Number: 2024168-2023-00072
• Device Sequence Number: 6717352
• Product Code: LOX
• UDI-Device Identifier: 08717648152092
• UDI-Public: 08717648152092
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 02/27/2023

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: 08/31/2025
• Device Model Number: 1012454-08
• Device Catalogue Number: 1012454-08
• Device Lot Number: 20924G1
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2022
• 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