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

Catalog Number	1012447-08
Medical Device Problem Codes	Inflation Problem (1310); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was returned for analysis.Visual and functional inspections were performed on the returned device.The reported inflation issue was confirmed.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 of the reported lot did not indicate a lot specific quality issue.The outer member was stretched proximal to the proximal seal and the outer member was folded inwards at the mid lap join possibly from inadvertent mishandling.It is possible that the noted folded inwards outer member at the midlap seal contributed to the reported difficulty; however, it is unknown when this damage occurred.The investigation was unable to determine a conclusive cause for the reported inflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.
Additional Manufacturer Narrative
Exemption number e2019001.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported the procedure was to treat lesion in the right coronary artery.The 2.5x08 mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion without issue.On inflation, the balloon of the bdc failed to inflate, no leak was noted.The bdc was removed without issue and was replaced with a new nc trek bdc to complete the procedure.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.Returned goods analysis noted the outer member of the bdc, proximal to the proximal seal was stretched.

• Brand Name: NC TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9344966
• Report Number: 2024168-2019-13758
• Device Sequence Number: 19372379
• Product Code: LOX
• UDI-Device Identifier: 08717648151743
• UDI-Public: 08717648151743
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 1012447-08
• Device Lot Number: 90716G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR