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

Model Number	1012455-08
Medical Device Problem Codes	Deflation Problem (1149); Product Quality Problem (1506); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat an 80% stenosed de novo lesion in the right coronary artery (rca) with moderate calcification and mild tortuosity.For post dilatation the 5x8mm nc trek balloon dilatation catheter (bdc) was advance to the target lesion and the balloon was inflated.However, the balloon was noted to take longer than usual to deflate.The bdc was removed from the patient and difficulty was noted with the guide catheter during removal.The physician felt the bdc was bulky.There was no adverse effect and no clinically significant delay reported in the procedure.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
A visual, dimensional, and functional inspection was performed on the returned device.The reported inflation problem could not be confirmed; however, operational circumstances may have contributed.The reported bulky feeling (product quality problem) could not be confirmed.The reported difficult to remove could not be tested as it was based on operational context.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the balloon dilation catheter (bdc) took longer than expected to deflate.A functional analysis was performed on the returned bdc.The bdc was inflated to rated burst pressure three times and the deflation time was measured.The deflation time was within specification.A bend on the hypotube was noted.A bend on the hypotube has the potential to limit contrast flow, possibly contributing to the reported deflation problem.It was also reported that the bdc encountered resistance during removal.It is possible that the balloon failed to fully deflate, due to the noted deflation problem.A not fully deflated balloon would impact the bdc¿s clearance with the guiding catheter, possibly resulting in the reported difficulty during removal.Additionally, a visual and dimensional examination was performed.No irregular appearance or anomalies were noted, it is unknown what contributed to the reported ¿bulky¿ feeling.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D1 correction: brand name updated d2a correction: common device name updated d3 correction: name, address updated.

• Brand Name: NC TREK
• 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: 19354685
• Report Number: 2024168-2024-06124
• Device Sequence Number: 7703122
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: (01)08717648152139(17)261031(10)31101G1
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 07/03/2024

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 Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 31101G1
• 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: 04/27/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 4.0 LAUNCHER JR GUIDE CATHETER; 4X33MM XIENCE SIERRA STENT PART#1500400-33 LOT#202
• Patient Sex: Unknown