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

Model Number	1012455-08
Medical Device Problem Codes	Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
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.Medical device problem code 2017: excessive force.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the coronary artery.The 5.0x8mm nc trek balloon dilatation catheter (bdc) was used and attempted to be retrieved; however, it was not possible to withdraw as the balloon was partially deflated, failed to refold and had a winged appearance despite several attempts to hold negative pressure.On the second attempt, the balloon was noted to be ruptured due the force applied; therefore, the bdc was removed with the guidewire and the guiding catheter.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported failure to fold and separation were confirmed.The reported difficulty removing the device and deflation issue could not be replicated in a testing environment due to the condition of the returned device.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 deflation issue; however, the reported failure to fold and difficulty removing the device appear to be related to circumstances of the procedure.The reported separation appears to be related to user error/operational context.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.A conclusive cause for the reported deflation issue could not be determined.In this case, it is likely that that a larger balloon size and/or deflation technique contributed to the reported failure to fold (winged balloon).Additionally, the reported deflation issue and failure to fold likely contributed to the resistance met with the guiding catheter during removal since the balloon would not fully deflate and upon manipulation of the device and use of force, against resistance, the device ultimately separated.It was reported by the account that force was applied during the attempt to remove the device and the shaft separated.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, it is likely that the violation of the ifu contributed to the reported separation as the device separated after pulling against resistance occurred.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: the code 1546 was deleted and 1562 added.
Event or Problem Description
Returned device analysis identified an inner and outer member separations separation; however, the account confirmed that the initially reported information described as a rupture had been describing the inner and outer member separation.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: 17317360
• Report Number: 2024168-2023-07471
• Device Sequence Number: 20389771
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/25/2023

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: 10/31/2025
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 21119G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2022
• 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
• Patient Sex: Unknown