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

Model Number 1012451-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 Description

It was reported that the procedure was to treat a calcified lesion in the mid left anterior descending (lad) coronary artery.After the first inflation of the 3.5x15 mm nc trek balloon dilatation catheter (bdc) to 14 atmospheres (atm), a perforation occurred.50 units of protamine was administered and a graftmaster covered stent was used to seal the perforation successfully.The patient also underwent pericardiocentesis for the effusion that occurred.The patient experienced a drop in blood pressure for about 3 minutes that was resolved after the pericardiocentesis.The patient was referred to surgery for non emergent bypass of the lad and other disease present in non-target vessels.The patient is stable and doing well.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record of the reported device could not be conducted because the lot number was not provided.The reported patient effects of perforation and hypotension are listed in the nc trek rx coronary dilatation catheter instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment(s) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9358912
• MDR Text Key: 167564214
• Report Number: 2024168-2019-13816
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 1012451-15
• Device Catalogue Number: 1012451-15
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 80 YR
• Patient Weight: 82