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

Model Number	1012446-15
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	09/14/2020
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 and relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents reported from this lot or relabeled lot.In this case, the device was prepped prior to use with no issue/ leak noted.The investigation determined the reported difficulty to advance and balloon rupture appear to be related to operational circumstances of the procedure.Based on the reported information, during advancement, the balloon catheter encountered resistance with the moderately calcified, mild tortuous, and 90% stenosed anatomy, likely causing damage to the outer surface of the balloon resulting in the reported balloon rupture during the first inflation at 14 atmospheres.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 distal right coronary artery that was 90% stenosed.The 2.25x15mm nc trek balloon dilatation catheter met resistance with the anatomy during advancement.The balloon ruptured at 14atm on the first inflation.The device was replaced with a new non-abbott nc balloon to 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: 10617153
• Report Number: 2024168-2020-08192
• Device Sequence Number: 11420849
• Product Code: LOX
• UDI-Device Identifier: 08717648151705
• UDI-Public: 08717648151705
• 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): 10/01/2020

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: 02/28/2022
• Device Model Number: 1012446-15
• Device Catalogue Number: 1012446-15
• Device Lot Number: 90319G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1