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

Model Number	1012455-08
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a left main stem coronary artery.Two 5x8mm nc trek balloons met resistance with a 6f non-abbott sheath during removal thus access wire was lost twice.Resistance was also reported to be had with the guide catheter.The balloons were fully deflated before attempted removal.The devices were removed altogether with the sheath.There was no report of adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
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.The additional nc trek device referenced is filed under a separate medwatch report number.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported difficulty removing the device from the introducer sheath and guiding catheter 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 of the reported lot did not indicate a lot specific quality issue.Additionally, it should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: with 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device from the introducer sheath and guiding catheter.However, factors that can contribute to difficult to remove/resistance with the introducer sheath and guiding catheter post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends or procedural technique.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.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 left main stem coronary artery.Two 5x8mm nc trek balloons met resistance with a 6f non-abbott sheath during removal thus access wire was lost twice.Resistance was also reported to be had with the guide catheter.The balloons were fully deflated before attempted removal.The devices were removed altogether with the sheath.There was no report of adverse patient effects and no clinically significant delay.Device analysis confirmed [stretching was noted on the outer member distal to the mid lap seal for a length of 0.5mm.] for one of the 5x8mm nc trek balloons.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: 13079205
• Report Number: 2024168-2021-12138
• Device Sequence Number: 5630106
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 05/31/2024
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 10602G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F CORDIS SHEATH
• Patient Sex: Unknown