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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, heavily tortuous left main artery.The 4.50x8mm nc trek would not deflate, however, after multiple deflations the device was pulled into the catheter and noted it was removed not inflated.Resistance was noted during removal with the unspecified balance middleweight guide wire.Another unspecified device was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional vascular device referenced in b5 is filed under separate medwatch report number.
Additional Manufacturer Narrative
The investigation determined the reported deflation issue and noted leak/tear on the returned device appear to be related to operational context; however, a conclusive cause for the reported difficulty removing the device could not be determined.Return device analysis and scanning electron (sem) analysis revealed a leak and mechanical damage (tear) in the inner member just proximal to the proximal marker.In this case, it is possible that the guide wire was inadvertently mishandled and/or front loaded at an angle such that the guide wire caused damage (tear) to the inner member resulting in the noted leak and subsequently the reported deflation issue.Additionally, possible factors that may contribute to difficulty removing over the guide wire include, but are not limited to, inner diameter of the catheter, outer diameter of the guide wire, device support, user technique, and/or damage to the catheter or guide wire.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.B5 - describe event or problem: updated.H10 - additional mfg narrative: revised.
Event or Problem Description
Subsequently, after the initial report was filed it was noted the nc trek balloon was slow to deflate and removed fully deflated through the catheter.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional, functional and scanning electron (sem) inspections/analysis were performed on the returned device.The reported difficulty removing the device was confirmed; however, the reported 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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported deflation issue, difficulty removing the device and noted leak/tear on the returned device appear to be related to operational context.Return device analysis and sem analysis revealed a leak and mechanical damage (tear) in the inner member just proximal to the proximal marker.In this case, it is possible that the guide wire was front loaded and inadvertently mishandled such that the guide wire caused damage (tear) to the inner member resulting in the noted leak and subsequently the reported deflation issue and 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: 16919454
• Report Number: 2024168-2023-05106
• Device Sequence Number: 15183662
• Product Code: LOX
• UDI-Device Identifier: 08717648152092
• UDI-Public: 08717648152092
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 09/22/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 09/13/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 09/12/2023; 09/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALANCE MIDDLEWEIGHT GUIDE WIRE.
• Patient Sex: Unknown