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

Model Number	1012451-20
Medical Device Problem Codes	Inflation Problem (1310); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.The outer member (shaft) was stretched at the location of the mid lap seal, possibly from inadvertent mishandling; however, it is unknown when these damages occurred.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 inflation issue.However, factors that may contribute to difficulty inflating may include, but are not limited to, damage to the inflation lumen, patient anatomical morphology and patient disease state.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
Event or Problem Description
It was reported that the procedure was performed to treat a chronic totally occluded lesion in the left circumflex artery.A 3.5x20mm nc trek rx balloon dilatation catheter (bdc) failed to inflate.The procedure was successfully completed with a new 3.5x20mm nc trek rx bdc.There were no adverse patient effects and no clinically significant delay in the procedure.The return device analysis identified that the outer member (shaft) was stretched at the location of the mid lap seal for a length of approximately.25mm.No additional information was provided.

• 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: 11408193
• Report Number: 2024168-2021-01707
• Device Sequence Number: 19811612
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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 Expiration Date: 08/31/2023
• Device Model Number: 1012451-20
• Device Catalogue Number: 1012451-20
• Device Lot Number: 00902G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1