MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK NEO¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1400500-20
Medical Device Problem Codes	Difficult to Insert (1316); Loose or Intermittent Connection (1371); Difficult to Remove (1528)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a 60% stenosed lesion in the left main coronary artery with moderate calcification.The 5x20mm nc trek neo balloon dilatation catheter (bdc) was used in the procedure.However, the hub of the bdc was noted to be very robust and difficulty was noted when fitting the pressure gauge syringe.After the balloon was inflated, the profile was found to be high making it difficult to retract the bdc into the guide catheter.After ballooning a leak in the left anterior descending (lad) was noted and a pericardial effusion was confirmed.Surgery was performed to drain the pericardial effusion.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the information provided, a definitive cause for the reported loose/intermittent connection and difficulty removing the device could not be determined; however, the reported surgical intervention and hospitalization or prolong hospitalization appear to be related to circumstance of the procedure.Additionally, a conclusive cause for the reported patient effect of pericardial effusion, and the relationship to the product, if any, cannot be determined.The reported patient effect of pericardial effusion is listed in the coronary dilatation catheters (cdc), nc trek neo, instruction for use as a known patient effect.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.E1: facility name updated from hospitaluniversitário cassianoantoniomoraes-hucam to unknown.E1: address updated from (b)(6) to unk.E1: city updated from (b)(6) to unk.E1: postal code updated from (b)(6) to unk.E1: phone number updated from +(b)(6) to ni.H6: medical device problem code 1316 removed, 1371 added.
Event or Problem Description
Subsequent to the initial report it was reported that the procedure was to treat a 60% stenosed lesion in the left main coronary artery with moderate calcification.No additional information was provided.

• Brand Name: NC TREK NEO¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20447152
• Report Number: 2024168-2024-12116
• Device Sequence Number: 18275789
• Product Code: LOX
• UDI-Device Identifier: 08717648232817
• UDI-Public: (01)08717648232817(17)261031(10)31121G1
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K220634
• 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): 12/13/2024

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 Model Number: 1400500-20
• Device Catalogue Number: 1400500-20
• Device Lot Number: 31121G1
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 87 KG