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

Catalog Number	1012450-12
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual, functional and sem inspections/analysis were performed on the returned device and identified a tear and a leak in the outer member.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 identified no other incidents/complaints from this lot.The investigation determined the reported complaint appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.Exemption number e2019001.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous left anterior descending artery.The 3.25x12mm rx trek balloon dilatation catheter (bdc) failed to inflate.A new unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis noted a tear and leak in the outer member.

• 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: 9176726
• Report Number: 2024168-2019-12507
• Device Sequence Number: 2614811
• Product Code: LOX
• UDI-Device Identifier: 08717648151927
• UDI-Public: 08717648151927
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/10/2019

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: 03/31/2022
• Device Catalogue Number: 1012450-12
• Device Lot Number: 90415G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1