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

Model Number	1012455-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2021
Type of Reportable Event	Malfunction
Additional 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.(b)(4).
Event or Problem Description
User facility medwatch [medwatch #: (b)(4) report received states: upon retrieval of the nc trek coronary dilatation catheter 5.0 mm x 20 mm / rapid exchange (post expansion) , the device became lodged in the guide catheter.As the doctor tugged a bit harder the balloon separated into two pieces.The doctor removed the entire system (balloon, guide wire and guide catheter) with the balloon remainder stuck in the guide catheter, but subsequently removed.No additional information was provided.
Additional Manufacturer Narrative
D9, h3: device status changed from returning to not returned.The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product were not performed because the lot number was not reported and the product was not returned for analysis.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter during removal causing the reported difficulty to remove.Handling of the device during removal likely caused the reported balloon separation as the account indicated hard tugging was used in an attempt to remove the device.The device, including the separated balloon portion, were removed with the guiding catheter as one unit.There is no indication of a product quality issue with respect to manufacture, design 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: 12542808
• Report Number: 2024168-2021-08697
• Device Sequence Number: 5338556
• Product Code: LOX
• UDI-Device Identifier: 08717648152160
• UDI-Public: 08717648152160
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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 Model Number: 1012455-20
• Device Catalogue Number: 1012455-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 44 YR
• Patient Sex: Unknown