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

Model Number 1012450-15

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was retained by the hospital.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The bmw guide wire (gw) referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a lesion the circumflex artery.The unspecified bmw guide wire (gw) was positioned in the vessel and after stent implantation, a 3.25x15mm nc trek balloon dilatation catheter (bdc) was advanced over the wire, but became stuck on the wire.The bdc could be retracted with difficulty, but the bdc and gw were removed as a single unit.There was no adverse patient effect reported and no clinically significant delay reported.Another gw and balloon were used for post-dilatation to complete the procedure.No additional information was provided.

Event Description

Subsequent to initial report, the following information was received: it was reported that the unspecified balance middle weight (bmw) guide wire (gw) was an ht bmw universal ii gw.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty advancing and removing the device from the guide wire.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported difficulty advancing the device over the guidewire was confirmed.The reported difficulty removing the device from the guidewire could not be replicated in a testing environment due to the condition of the returned device.Additionally, a tear was noted in the distal to mid lap seal.The investigation was unable to determine a conclusive cause for the reported difficulty advancing and removing the device from the guide wire or the noted tear in the outer member distal to the mid lap seal.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9, h3; device was available for evaluation.H6:type of investigation code 4114 - removed.

• 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: 15205032
• MDR Text Key: 303923574
• Report Number: 2024168-2022-08694
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151934
• UDI-Public: 08717648151934
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012450-15
• Device Catalogue Number: 1012450-15
• Device Lot Number: 20208G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2022
• 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: BMW GUIDEWIRE.
• Patient Sex: Female