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

Catalog Number	1012455-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca).The 5.0x12mm nc trek balloon dilatation catheter (bdc) was used in the procedure; however, the balloon failed to deflate.Resistance was noted with the guide catheter during removal and the balloon separated [broke off].A snare device and an entrapment balloon was used to remove the separated balloon.There was no adverse patient sequela.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.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported failure to deflate could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty removing the device from the guiding catheter was confirmed; however, the reported balloon separation was not.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.It was reported that the contrast mix used for the procedure was 20ml contrast and 10ml saline.Return analysis noted significant contrast buildup in the balloon and in the inflation lumen.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use (ifu) specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.Contrast that is more concentrated can lead to slower inflation and deflation times.In this case, it is likely that the concentrated contrast solution contributed to the reported failure to deflate.The reported difficulty removing the device from the guiding catheter likely resulted from the balloon experiencing deflation issues.As difficulty was encountered during removal and the device was manipulated in an attempt to remove it, it is possible that it gave the impression of a separated balloon; however, a conclusive cause could not be determined for the separation as return analysis was unable to confirm it.Unexpected medical intervention was performed to complete the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.B3: date of procedure updated to (b)(6) 2023 from estimated date of (b)(6) 2023.B5: describe event or problem: updated.H6: device code 2017 - contrast incorrect has been added.
Event or Problem Description
Return device analysis found the balloon was not separated as reported.Additionally a.014" abbott bmw universal ii guide wire was frozen in the guide wire lumen of the nc trek balloon catheter.Additionally, follow up with the account report that incorrect contrast ratio had been used.No additional information was provided.

• Brand Name: NC TREK RX 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: 18096775
• Report Number: 2024168-2023-12437
• Device Sequence Number: 7046649
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: 08717648152146
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 1012455-12
• Device Lot Number: 30221G1
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown