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

Model Number	1012453-08
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.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 proximal left anterior descending coronary artery that was mildly calcified and non-tortuous.A 3.0x33mm skypoint stent was successfully implanted and was post-dilated with two nc trek balloon dilatation catheters (bdc), a 3.5x15mm, and a 4.0x8mm.The 4.0x8mm was inflated once to 16 atmospheres (atm) for 20 seconds.During removal of the 4.0x8mm nc trek bdc, it could not be fully retracted into the guide catheter, so the devices were removed as a single unit.After the device was removed, it was noted that the balloon was still partially inflated.There was no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device.The reported deflation was confirmed; however, the reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 deflation issue; 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.

• 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: 13592786
• Report Number: 2024168-2022-01976
• Device Sequence Number: 14893279
• Product Code: LOX
• UDI-Device Identifier: 08717648152054
• UDI-Public: 08717648152054
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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: 08/31/2024
• Device Model Number: 1012453-08
• Device Catalogue Number: 1012453-08
• Device Lot Number: 10915G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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 Sex: Unknown