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

Model Number	1012455-15
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the ostial right coronary artery with no calcification and no tortuosity.An nc trek rx balloon dilatation catheter (bdc) was advanced to the target lesion without issue.After inflation to about 14 atmospheres, the balloon only partially deflated.Several attempts were made to deflate the balloon, but the balloon only partially deflated.The device was retracted back, and after a few tugs, the balloon was freed from the rca, ending the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported deflation issue was unable to be performed due to the returned condition of the device.The reported difficulty to remove was unable to be replicated in a testing environment as it was based on operational circumstances.Of note, the balloon inner member was separated at the distal seal.The outer member was stretched proximal to the proximal seal.The inner and outer member were stretched and twisted distal to the mid lap seal.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incidents there is no indication of a lot specific product quality issue.There was no damage noted to the balloon catheter during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the balloon was not given enough time to deflate during the initial deflation causing resistance during retraction, and likely causing damage to the outer member at the proximal seal.Additional manipulation and tugging against resistance ultimately resulted in the noted subsequent damages to the inner and outer members.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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
• MDR Report Key: 10382461
• Report Number: 2024168-2020-06622
• Device Sequence Number: 16613116
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: 08717648152153
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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 Expiration Date: 06/30/2021
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 80719G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1