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

Model Number	1012445-08
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - estimated.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 in june of 2020, a 2x8mm nc trek balloon dilatation catheter (bdc) failed to inflate during use.There was no reported adverse patient effect or a clinically significant delay in procedure.There was no additional information provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.The balloon was tightly folded, consistent with what was reported.A proxy guide wire was used to backload through the guide wire lumen to support the shaft and a proxy indeflator, filled with water was used to inflate the balloon and the balloon fully inflated to rate burst pressure (rbp) of 18 atmospheres with no anomalies noted, thus the reported complaint was not 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 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.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.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: 11423308
• Report Number: 2024168-2021-01746
• Device Sequence Number: 11781452
• Product Code: LOX
• UDI-Device Identifier: 08717648151637
• UDI-Public: 08717648151637
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 07/31/2020
• Device Model Number: 1012445-08
• Device Catalogue Number: 1012445-08
• Device Lot Number: 70809G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1