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

Model Number 1012449-12

Device Problem Material Rupture (1546)

Patient Problem Atrial Fibrillation (1729)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 Description

It was reported that the procedure was performed to treat a lesion in the right coronary artery.A 3.0x12mm nc trek rx balloon dilatation catheter (bdc) was prepared per the instructions for use.The balloon ruptured during the first inflation before reaching 14 atmospheres.The patient developed atrial fibrillation and cardioversion was performed to successfully get the patient was out of danger.No additional information was provided.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported additional treatment appears to be related to operational context.A conclusive cause for the reported patient effect of atrial fibrillation and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 9372403
• MDR Text Key: 168218574
• Report Number: 2024168-2019-13910
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151866
• UDI-Public: 08717648151866
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 1012449-12
• Device Catalogue Number: 1012449-12
• Device Lot Number: 90606G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 02/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention