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

Model Number	1012447-20
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, moderately calcified bifurcated left anterior descending and diagonal artery.While advancing a 2.5x20 nc trek balloon resistance was met with the anatomy and 2 unspecified guide wires.When removing the device the distal shaft became separated and a snare was used to retrieve it.There was no adverse patient sequela reported.Another unspecified device was used to successfully complete the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, moderately calcified bifurcated left anterior descending and diagonal artery.While advancing a 2.5x20 nc trek balloon resistance was met with the anatomy and 2 unspecified guide wires.When removing the device the distal shaft became separated and a snare was used to retrieve it.There was no adverse patient sequela reported.Another unpspecified device was used to successfully complete the procedure.No additional information was provided.(b)(6) 2020: medwatch report received today stating: [the shaft of the inferior branch balloon broke with retained distal shaft and balloon in the coronary artery.The distal balloon catheter device was snared and completely removed from the body.].
Additional Manufacturer Narrative
The device was not returned 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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3: device status changed from returning to discarded.

• 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: 9639956
• Report Number: 2024168-2020-00952
• Device Sequence Number: 14150974
• Product Code: LOX
• UDI-Device Identifier: 08717648151774
• UDI-Public: 08717648151774
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1012447-20
• Device Catalogue Number: 1012447-20
• Device Lot Number: 90509G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/08/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR