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

Model Number 1012453-12

Device Problems Failure to Fold (1255); Difficult to Remove (1528)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the left anterior descending coronary artery.A 4x12mm nc trek balloon dilatation catheter (bdc) was used but the balloon did not refold tightly.The bdc faced resistance with an unspecified guiding catheter during removal, but they were removed together without further issue to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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 complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9, h3: device was not available for evaluation.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported failure to fold (winged balloon) was confirmed.The reported difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.The investigation was unable to determine a conclusive cause for the reported failure to fold (winged balloon); however, the reported difficulty removing the device appears 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.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: 12829967
• MDR Text Key: 283301558
• Report Number: 2024168-2021-10487
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152061
• UDI-Public: 08717648152061
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012453-12
• Device Catalogue Number: 1012453-12
• Device Lot Number: 10722G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• 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