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

Model Number 1012447-20

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

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

Event Date 09/16/2022

Event Type  malfunction  

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.The additional devices referenced in b5 are being filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat a bifurcation in the first diagonal artery.The 2.5x20mm nc trek rx balloon dilatation catheter (bdc) was prepared and flushed prior to use but was difficult to advance trapping the distal part of the hi-torque (ht) balance middleweight (bmw) universal ii guide wire.The guide wire had resistance upon removal with the balloon catheter and some force was applied breaking the proximal core of the guide wire but remaining intact.The guide wire and the balloon were simply removed together.Another guide wire and balloon were used to complete the procedure.Another balloon was difficult to advance over another ht bmw universal ii guide wire in the anterior descending artery to perform the final kissing balloon technique (kbt) requiring the guide wire to be changed.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty advancing and removing the device over the guide wire was not confirmed.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.Factors that may contribute to the difficult advancing and removing the bdc from the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, device placement technique, buildup of procedural contaminants in the guide wire lumen, guiding catheter support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, or damage to the distal shaft of the catheter.In this case, a conclusive cause for the reported difficulty could not be determined since the complaints could not be confirmed during return analysis.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a bifurcation in the first diagonal artery.The 2.5x20mm nc trek rx balloon dilatation catheter (bdc) was prepared and flushed prior to use but was difficult to advance trapping the distal part of the hi-torque (ht) balance middleweight (bmw) universal ii guide wire.The guide wire had resistance upon removal with the balloon catheter and some force was applied breaking the proximal core of the guide wire but remaining intact.The guide wire and the balloon were simply removed together.Another guide wire and balloon were used to complete the procedure.Another balloon was difficult to advance over another ht bmw universal ii guide wire in the anterior descending artery to perform the final kissing balloon technique (kbt) requiring the guide wire to be changed.There was no adverse patient effect and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the ht bmw universal ii guide wire did not separate in the patient's anatomy and it was confirmed there was nothing left in the patient.No additional information was provided.

• 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: 15533454
• MDR Text Key: 306424798
• Report Number: 2024168-2022-10251
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151774
• UDI-Public: 08717648151774
• 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
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012447-20
• Device Catalogue Number: 1012447-20
• Device Lot Number: 20223G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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: HT BMW UNIVERSAL GUIDE WIRE
• Patient Sex: Female