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

Model Number 1012453-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

The other additional vascular device's referenced are being filed under a separate medwatch report number.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.On (b)(6) 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter.The field safety action number is 2024168-1/27/2020-001.This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter.Product from identified lots may exhibit slow, partial or failure to deflate.

Event Description

It was reported that the procedure was performed to treat the left main (lm) to the proximal left anterior artery (plad).A kissing balloon technique was done by inflating a 2.75x15mm rx nc trek balloon dilatation catheter (bdc) in the left circumflex and a 4.0x15mm rx nc trek bdc in the lm ¿ plad.Both balloons were pressurized to 8 atmospheres.Both balloons were deflated multiple times as they deflated slowly.While retrieving the 4.0x15mm nc trek, the balloon got stuck with the newly deployed 3.5x15mm xience sierra stent and broke the stent into two parts.The proximal portion of the separated stent was retrieved with the balloon.A snare device was used to retrieve the distal portion of the stent.During retrieval, the broken stent struts caught and explanted a 2.75x48mm xience xpedition stent that had been implanted on (b)(6) 2019 in the mlad.A new unspecified stent was deployed to cover the entire lad.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue could not be confirmed.The reported difficulty removing the device from the stent and device damaged by another device could not be replicated in a testing environment as it was due to operational context.A review of the lot history record identified one 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 reported difficulty removing the device from the stent and device damaged by another device appear to be related to operational context.The investigation determined the reported deflation issue is related to a manufacturing issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 9688757
• MDR Text Key: 178592221
• Report Number: 2024168-2020-01327
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• 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,foreig
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 90904G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.75X15MM RX NC TREK; GUIDEWIRE - RUNTHROUOGH NS; GUIDEWIRE - ASAHI; GUIDING CATHETER - LAUNCHER; XIENCE SIERRA 3.5X15