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

Model Number	1012445-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional nc trek device is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that a 2.0x12mm nc trek rx balloon dilatation catheter (bdc) was advanced; however, the shaft separated.The bdc was removed.A 2.0x15mm nc trek rx bdc was advanced and again the shaft separated.The bdc was removed.In both cases, the separations made it more complex during removal.The procedure was successfully completed with another unspecified balloon catheter.There were no adverse patient effects and no reported clinically significant delay.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported separation; however, the difficulty removing the device 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 the device.

• 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: 9957572
• Report Number: 2024168-2020-03631
• Device Sequence Number: 2596178
• Product Code: LOX
• UDI-Device Identifier: 08717648151644
• UDI-Public: 08717648151644
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 10/31/2022
• Device Model Number: 1012445-12
• Device Catalogue Number: 1012445-12
• Device Lot Number: 91105G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1