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

Model Number	1012453-08
Medical Device Problem Codes	Deflation Problem (1149); Product Quality Problem (1506); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
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.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca).After post dilatation, the 4.0x8mm nc trek balloon dilatation catheter (bdc) did not deflate sufficiently and was difficult to fully pull back into the guide catheter (gc).The bdc was eventually pulled back into the gc with the balloon protruding out of the distal end out of the radial sheath and was removed from the anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was received: it was not confirmed that it was reported that there was a deflation issue.The device was difficult to remove.No additional information provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported unknown damage (wrinkled/bunched balloon) and difficulty removing the device were confirmed.Return analysis noted the distal end of the balloon was wrinkled and bunched, which is likely what the account perceived as the unknown damage when they reported that, ¿the balloon did not deflate sufficiently.¿ 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 unknown damage (wrinkled/bunched balloon); however, the reported difficulty removing the device appears to be related to circumstances of the procedure.In this case, it is possible that deflation technique and/or a large balloon profile contributed to the noted failure to fold of the balloon (wrinkled/bunched); however, a conclusive cause cannot be determined since limited information was provided by the account.Additionally, it is likely that the noted failure to fold of the balloon (wrinkled/bunched) resulted in the reported difficulty removing the device as the balloon did not refold uniformly and interacted with the tip of the guiding catheter.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: medical device problem code 1149 - removed.

• 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: 16161968
• Report Number: 2024168-2023-00480
• Device Sequence Number: 7005886
• Product Code: LOX
• UDI-Device Identifier: 08717648152054
• UDI-Public: 08717648152054
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 10/31/2025
• Device Model Number: 1012453-08
• Device Catalogue Number: 1012453-08
• Device Lot Number: 21108G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2022
• 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