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

Model Number	1012449-15
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous unspecified lesion.A 3.0x15mm nc trek balloon dilatation catheter (bdc) was advanced to cross the lesion; however, blood was noted in the inflation device and the bdc was removed.It was noted the bdc was not air aspirated prior to use.An unspecified device was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.
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.Device code 2017 - failure to follow steps / instructions.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported leak was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported that the device was not prepared (air aspiration) outside the anatomy.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) specifies: all air must be removed from the balloon and displaced with contrast prior to inserting into the body, otherwise, complications may occur.In this case, it is unknown if the violations of the ifu caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported leak.Return analysis noted a tear in the outer member, distal to the mid lap seal which resulted in the reported leak.Upon further evaluation through sem analysis it was noted that the leak area exhibited a pinched appearance with mechanical damage at the leak edges.In this case, it is possible that the bdc was inadvertently mishandled during unpackaging and/or interacted with equipment or accessory devices in the procedure room resulting in the noted damage; however, a conclusive cause cannot be determined, and it is unknown when the damage occurred.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 16437769
• Report Number: 2024168-2023-01896
• Device Sequence Number: 3136581
• Product Code: LOX
• UDI-Device Identifier: 08717648151873
• UDI-Public: 08717648151873
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 05/31/2023

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: 07/31/2025
• Device Model Number: 1012449-15
• Device Catalogue Number: 1012449-15
• Device Lot Number: 20825G1
• 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: 01/30/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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