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

Catalog Number	1012452-20
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was unable to determine a conclusive cause for the reported inflation issue, leak or difficulty removing the device; however, the reported separation appears 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.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.
Event or Problem Description
It was reported that this was a percutaneous coronary intervention (pci) treating a proximal left anterior descending (lad) lesion.For post-dilatation, an nc trek advanced over a run through wire and to a previously implanted, unspecified stent without issues.Balloon inflation was attempted, however, failed and blood was noted in the device and contrast in the vessel.It was decided to remove the nc trek.During removal, resistance was felt at the copilot site and the shaft had then separated approximately 25 cm from the tip.The device was removed without further issues.Once outside the anatomy, the balloon appeared fine, without any material separation noted.The rest of the procedure was completed without further issues and with the same copilot device.Reportedly, there was no issue with the copilot.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

• 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: 8907653
• Report Number: 2024168-2019-10942
• Device Sequence Number: 16827093
• Product Code: LOX
• UDI-Device Identifier: 08717648152047
• UDI-Public: 08717648152047
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 08/19/2019

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: 05/31/2022
• Device Catalogue Number: 1012452-20
• Device Lot Number: 90613G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/19/2019
• 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: COPILOT; RUNTHROUGH GUIDE WIRE