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

Model Number	1012447-08
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 reported from this lot.In this case, the device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure.It is likely that during advancement through the moderately calcified, moderately tortuous anatomy, the balloon became compromised and/or damaged resulting in the balloon rupture during the first inflation.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous de novo mid-left circumflex.The 2.50x8mm nc trek balloon ruptured at 6atm on the first inflation.The device was replaced with a new 2.5x12mm nc trek balloon to successfully continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: NC TREK RX & VOYAGER NC
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10146123
• Report Number: 2024168-2020-04946
• Device Sequence Number: 16907536
• Product Code: LOX
• UDI-Device Identifier: 08717648151743
• UDI-Public: 08717648151743
• 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): 06/11/2020

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: 08/31/2022
• Device Model Number: 1012447-08
• Device Catalogue Number: 1012447-08
• Device Lot Number: 90927G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1