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

Model Number 1012455-12

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly calcified, heavily tortuous, 80% re-stenosed stent in the right coronary artery (rca).A 5x12mm nc trek balloon dilatation catheter (bdc) was used to dilatate the lesion, however during removal, the balloon shaft separated into two pieces and the separated piece remained in the sheath.A guide wire with an unspecified armada balloon, were used to pin the separated piece of the balloon and pull it out of the tip of the sheath to remove it while maintaining access with the sheath.The procedure was concluded at that point.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulty removing the device, separation, removal of foreign body and unexpected medical intervention appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Manufacturer Narrative

Visual and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.Additionally, the inner member and outer member were confirmed separated.The investigation determined the reported shaft separation and confirmed inner member separation distal to the guidewire exit notch and the outer member separation at the mid lap seal during return analysis appear to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: 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: 14952050
• MDR Text Key: 295472445
• Report Number: 2024168-2022-07349
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: 08717648152146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012455-12
• Device Catalogue Number: 1012455-12
• Device Lot Number: 20215G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARMADA BALLOON.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 58 KG