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

Catalog Number	1012449-12
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Angina (1710); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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.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 an 80% stenosed left anterior descending (lad) artery with mild calcification and mild tortuosity.The 3x12mm nc trek balloon dilatation catheter (bdc) was used in the procedure; however, the balloon would not deflate.Therefore, the balloon was inflated and deflated again and the balloon was able to be deflated.However, the balloon deflation was noted to be slow.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat an 80% stenosed left anterior descending (lad) artery with mild calcification and mild tortuosity.The 3x12mm nc trek balloon dilatation catheter (bdc) was used in the procedure; however, the balloon would not deflate.Therefore, the balloon was inflated and deflated again and the balloon was able to be deflated.However, the balloon deflation was noted to be slow.There was no adverse patient effect and no clinically significant delay reported in the procedure.Subsequent to the previously filed report, further review of the information found that while the balloon was being inflated the patient experienced blocked blood flow and chest pain; however, the blood flow was resolved upon deflation and removal of the balloon.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 revealed no other incidents and/or complaints reported from this lot.Based on the information provided, a definitive cause for the reported deflation issue could not be determined.The reported obstruction/occlusion and angina appear to be a result of the slow deflation.The reported patient effects obstruction/occlusion and angina are listed in the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use, as known possible adverse effects.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B1 - adverse event/product problem updated.B5 - describe event or problem updated.H1 - type of reportable event updated.H6: device codes 2199, 4582 removed and 2422, 4614 and 1710 added.

• 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: 18833136
• Report Number: 2024168-2024-02715
• Device Sequence Number: 12627062
• Product Code: LOX
• UDI-Device Identifier: 08717648151866
• UDI-Public: 08717648151866
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/08/2024

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: 08/31/2026
• Device Catalogue Number: 1012449-12
• Device Lot Number: 30918G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• 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: Other
• Patient Sex: Unknown