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

Model Number	1012451-15
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during device preparation, the 3.5x15mm nc trek balloon dilatation catheter (bdc) was dipped in a bowl of water and inflation was attempted; however, bubbles were noticed from the tip of bdc.The device was not used.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided regarding this device issue.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was reported: it was reported that the procedure was to treat a moderately calcified, heavily tortuous, de novo lesion in the left anterior descending (lad) artery.During the procedure, a 3.5x15mm nc trek balloon dilatation catheter (bdc) was attempted to be inflated, however when pressure was released and made negative, blood came to the hub.There was no adverse patient effect and no clinically significant delay in the procedure.A non-abbott device was then prepared and used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported inflation issue and leak were confirmed.Additionally, inner and outer member damage was noted.A review of the lot history record identified one 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 determined a potential product quality issue based on the noted inner and outer member damage found during sem analysis and the confirmed reported leak and inflation issue during return analysis.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.H6: health effect - impact code 2645 - removed.

• 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: 13214204
• Report Number: 2024168-2022-00345
• Device Sequence Number: 17476233
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• 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
• Report Date (Section B): 05/19/2022

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: 05/31/2024
• Device Model Number: 1012451-15
• Device Catalogue Number: 1012451-15
• Device Lot Number: 10612G1
• 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: 12/19/2021
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2021
• 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
• Patient Sex: Unknown