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

Catalog Number	1012445-12
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for evaluation.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 from this lot.The investigation determined the reported difficulty advancing appears to be related to operational context; however, a conclusive cause for the reported balloon rupture could not be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.A 2.0 x 12mm nc trek balloon met resistance with the anatomy during advancement but was able to reach the lesion.Then once inflated the balloon ruptured at 18 atmospheres.An unspecified balloon was used to complete the procedure.There was no adverse patient effects or clinically significant delay in the procedure.No additional information was provided.

• 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: 9291758
• Report Number: 2024168-2019-13324
• Device Sequence Number: 11228552
• Product Code: LOX
• UDI-Device Identifier: 08717648151644
• UDI-Public: 08717648151644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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: 1012445-12
• Device Lot Number: 90424G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1