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

Catalog Number	1012449-25
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Foreign Body In Patient (2687)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a narrow lesion in the distal posterior tibial artery with moderate calcification.A 3.0 x 25 mm nc trek balloon dilation catheter (bdc) was advanced to the target lesion, and balloon angioplasty was performed.However, there was resistance during removal of the bdc, and excessive force was applied.The distal end of the catheter became detached inside the patient, and became embedded with the stent.The patient remains hospitalized and the separated portion was not retrieved.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
G9: 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 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 as it is likely that during removal interaction with the moderately calcified and narrow anatomy resulted in the reported difficulty to remove.Manipulation of the device resulted in the reported material separation.As reported, an unspecified stent was deployed to embed the detached portion of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: patient code 2687 removed.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: there was resistance during removal of the 3.0 x 25 mm nc trek balloon dilation catheter (bdc) due to the anatomy when the distal end of the bdc became detached.An unspecifed stent was deployed to embed the detached portion of the bdc.No additional information was provided.

• 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: 9465741
• Report Number: 2024168-2019-14494
• Device Sequence Number: 4115123
• Product Code: LOX
• UDI-Device Identifier: 08717648151897
• UDI-Public: 08717648151897
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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): 01/17/2020

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: 01/31/2021
• Device Catalogue Number: 1012449-25
• Device Lot Number: 80223G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/17/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 80