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

Model Number	1012451-20
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiogenic Shock (2262)
Date of Event	10/13/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.The device was not returned for analysis.A review of the lot history record and a similar incident review of the reported lot could not be conducted because the lot number was not provided.It should be noted that the reported patient effect(s) of perforation, hypotension and death are listed in the nc trek rx coronary dilatation catheter instructions for use as a known patient effect(s) of coronary stenting procedures.The investigation determined the reported difficult to remove appears to be related to circumstances of the procedure as it is likely that during retraction interaction with the guideliner resulted in the reported difficult to remove.The reported difficulties possibly contributed to the reported patient effects; however, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
Event or Problem Description
It was reported that on (b)(6) 2020, a percutaneous coronary intervention was performed on the mid left anterior descending (lad) coronary artery lesion.A 3.5x20mm nc trek rx advanced and dilated the mid lad lesion without a device issue.During retraction of the nc trek into the guideliner, resistance was met and a perforation occurred.The nc trek was retracted out of the anatomy without any other device issue noted.Balloon angioplasty was performed and a xience stent was successfully implanted.Following, a 3.5x19mm graftmaster stent was successfully implanted, sealing the perforation.After approximately 15 minutes post-procedure, the patients became hypotensive and bradycardic.Medications were provided and a pericardiocentesis was performed with no significant amount of blood observed.Per echocardiogram, the perforation site had expanded into the collaterals.The graftmaster stent remained sealing the intended implantation site, without a device malfunction.The perforation was larger than the graftmaster stent and there was no device malfunction.The patient went into cardiac shock with pulseless electrical activity.Medications were provided and cardio-pulmonary resuscitation (cpr) was performed.The patient expired that same day.Reportedly, there was no graftmaster device malfunction.Per physician, the graftmaster device did not cause or contribute to complications nor adverse events.No additional information was provided regarding this issue.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10818049
• Report Number: 2024168-2020-09381
• Device Sequence Number: 1926413
• Product Code: LOX
• UDI-Device Identifier: 08717648151996
• UDI-Public: 08717648151996
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/10/2020

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 Model Number: 1012451-20
• Device Catalogue Number: 1012451-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/10/2020
• 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: Death
• Patient Age: 83 YR
• Patient Weight: 84