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

Model Number	1012450-08
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the moderately calcified, moderately tortuous right coronary artery.A 3.25x8mm nc trek balloon dilatation catheter (bdc) was prepped with difficulty and was not soaked prior to use.The bdc was advanced without resistance, and inflation was initiated when a leak was immediately noted from the balloon.A non-abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device and the reported preparation issue and balloon rupture were unable to be confirmed due to the torn outer member.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 reported from this lot.It should be noted that the nc trek rx, global, instructions for use states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, the reported ifu violation of the device not soaked prior to preparation did not cause or contribute to the reported outer member tear or rupture.In this case, although there were issues during prep, the device was able to prep without any leaks noted, which would suggest that the device was not damaged prior to use.The investigation was unable to determine a conclusive cause for the reported difficulty to prep the deice or material rupture.The noted scratch on the outer member also suggests interaction causing possible damage to the outer surface of the outer member material.The noted bends on the hypotube likely occurred during packing for return analysis.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: 10292439
• Report Number: 2024168-2020-05961
• Device Sequence Number: 3624227
• Product Code: LOX
• UDI-Device Identifier: 08717648151910
• UDI-Public: 08717648151910
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 01/31/2023
• Device Model Number: 1012450-08
• Device Catalogue Number: 1012450-08
• Device Lot Number: 00221G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1