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

Model Number	1012447-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.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.
Event or Problem Description
It was reported that a 2.75x18mm xience pro a and 3.0x26mm non-abbott stents were implanted in the left anterior descending coronary artery.Post dilatation was to be attempted with a 2.50x20mm nc trek balloon dilatation catheter (bdc); however, huge resistance was noted during advancement due to interaction of devices.It was not clear which stent the bdc interacted with as the stents were directly after each other.The shaft kinked at two positions.Resistance with the previously placed stents or the guiding catheter was noted during withdrawal.After retracting the bdc, the distal shaft separated into two pieces outside the anatomy, nothing remained in the anatomy.The procedure was successfully completed with another 2.50x20mm nc trek.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 and/or complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Correction: device evaluated by mfr - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported shaft separation and kink were confirmed; however, the reported difficulty removing the device from the guiding catheter could not be confirmed.The reported failure to advance and difficulty removing the device from the anatomy could not be replicated in a testing environment as they are based on operational circumstances.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 and/or complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.D10, h3 - it was reported that the device would not be returning for analysis; however, the device was returned for evaluation.H6: method code 4115 was removed.

• 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: 9147846
• Report Number: 2024168-2019-12320
• Device Sequence Number: 16810490
• Product Code: LOX
• UDI-Device Identifier: 08717648151774
• UDI-Public: 08717648151774
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/28/2020

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: 12/31/2021
• Device Model Number: 1012447-20
• Device Catalogue Number: 1012447-20
• Device Lot Number: 90129G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 10/21/2019; 01/21/2020
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/08/2019; 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.75X18MM XIENCE PROA; 3.0X26MM MEDTRONIC RESOLUTE